28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
臨床試験数 : 261 / 薬物数 : 276 - (DrugBank : 81) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 178
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05145816 (ClinicalTrials.gov) | April 1, 2022 | 23/11/2021 | Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis | A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis | AL Amyloidosis;Amyloidosis | Drug: Belantamab mafodotin 2.5 mg/kg (6 weeks);Drug: Belantamab mafodotin 2.5 mg/kg (4 weeks);Drug: Belantamab mafodotin 2.5 mg/kg (8 weeks);Drug: Belantamab mafodotin 1.9 mg/kg (8 weeks);Drug: Belantamab mafodotin 1.9mg/kg or 2.5mg/kg every 4 weeks, 6 weeks or 8 weeks as determined by Part 1 recommended dosages | University of Texas Southwestern Medical Center | GlaxoSmithKline | Not yet recruiting | 18 Years | N/A | All | 37 | Phase 1/Phase 2 | United States |
| 2 | NCT05184088 (ClinicalTrials.gov) | April 2022 | 6/1/2022 | Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis | An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis | Cardiac Amyloidosis;AL Amyloidosis;ATTR Amyloidosis | Drug: [18F]florbetaben | Life Molecular Imaging GmbH | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | Phase 3 | NULL |
| 3 | EUCTR2021-002639-48-ES (EUCTR) | 08/03/2022 | 28/12/2021 | A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis | A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis - Aquarius | Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: Amyloid light-chain amyloidosis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: DAZARLEX Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JNJ-54767414 INN or Proposed INN: Daratumumab Other descriptive name: HuMax-CD38, 3003-005 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | France;United States;Greece;Canada;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | NCT04984330 (ClinicalTrials.gov) | March 2022 | 29/7/2021 | Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease | Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease | Amyloid;Amyloidosis;AL Amyloidosis | Drug: Selinexor;Drug: Dexamethasone | Weill Medical College of Cornell University | Karyopharm Therapeutics Inc | Recruiting | 18 Years | N/A | All | 10 | Early Phase 1 | United States |
| 5 | EUCTR2021-000037-14-NL (EUCTR) | 22/02/2022 | 04/08/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 6 | EUCTR2021-000037-14-IT (EUCTR) | 21/01/2022 | 26/11/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standardof Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. PlaceboPlus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis - NA | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains.Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits ofabnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, andhepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: [Birtamimab] INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid Product Name: paracetamolo Zentiva Italia Product Code: [NA] INN or Proposed INN: PARACETAMOLO Trade Name: Bortezomib Accord Product Name: Bortezomib Accord Product Code: [Bortezomib Accord] INN or Proposed INN: BORTEZOMIB Other descriptive name: Bortezomib D-mannitol Product Name: Zirtec Product Code: [NA] INN or Proposed INN: CETIRIZINA DICLORIDRATO Other descriptive name: NA Product Name: Aciclin Product Code: [NA] INN or Proposed INN: ACICLOVIR | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Portugal;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Germany;Netherlands;Korea, Republic of | ||
| 7 | NCT05235269 (ClinicalTrials.gov) | November 30, 2021 | 10/12/2021 | A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis | A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitation Repeatability of 124I AT-01 Using Positron Emission Tomography/X-ray Computed Tomography (PET/CT) in Subjects With Systemic Amyloidosis | Amyloidosis | Drug: I124-AT01 only | Attralus, Inc. | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 8 | NCT05199337 (ClinicalTrials.gov) | November 30, 2021 | 9/1/2022 | Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis | A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis | Amyloidosis;AL Amyloidosis | Drug: ZN-d5 | K-Group Alpha, Inc. | NULL | Recruiting | 18 Years | N/A | All | 135 | Phase 1/Phase 2 | United States |
| 9 | NCT05201911 (ClinicalTrials.gov) | November 30, 2021 | 2/12/2021 | A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis | A Single Arm, Single Dose Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Select Organs in Patients With Systemic Amyloidosis | Amyloidosis; Systemic | Drug: 124I-AT03 | Attralus, Inc. | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 10 | EUCTR2021-000037-14-DE (EUCTR) | 12/11/2021 | 26/05/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 11 | NCT04847453 (ClinicalTrials.gov) | September 14, 2021 | 15/4/2021 | Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis | A Phase 1/1a Study of Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for Relapsed/Refractory Light Chain Amyloidosis | Recurrent AL Amyloidosis;Refractory AL Amyloidosis | Procedure: Bone Marrow Aspiration and Biopsy;Drug: Dexamethasone;Drug: Ixazomib Citrate;Drug: Venetoclax | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 6 | Phase 1 | United States |
| 12 | EUCTR2021-000037-14-PT (EUCTR) | 10/09/2021 | 28/05/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 13 | EUCTR2021-000037-14-DK (EUCTR) | 01/09/2021 | 28/04/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Denmark;Australia;Netherlands;Germany;Korea, Republic of | ||
| 14 | NCT04882735 (ClinicalTrials.gov) | September 2021 | 29/4/2021 | Efficacy and Safety of Acoramidis (AG10) in Subjects With Transthyretin Amyloid Polyneurophathy (ATTRibute-PN) | A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate the Efficacy and Safety of Acoramidis in Subjects With Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Study) | Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy | Drug: Acoramidis | Eidos Therapeutics | NULL | Not yet recruiting | 18 Years | 90 Years | All | 100 | Phase 3 | NULL |
| 15 | NCT04973137 (ClinicalTrials.gov) | August 30, 2021 | 1/7/2021 | A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis | Light Chain (AL) Amyloidosis | Drug: Birtamimab;Other: Placebo;Drug: Standard of Care Chemotherapy | Prothena Biosciences Ltd. | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Australia;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom |
| 16 | EUCTR2021-000037-14-PL (EUCTR) | 20/08/2021 | 02/06/2021 | English: A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | English: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 17 | NCT05028374 (ClinicalTrials.gov) | August 17, 2021 | 23/8/2021 | COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies | Phase II Trial Evaluating the Efficacy of Moderna COVID-19 Vaccine Booster Dosing in Patients With Hematologic Malignancies Who Did Not Have an Adequate Response to Prior Vaccination | Multiple Myeloma;AL Amyloidosis;Chronic Lymphocytic Leukemia | Drug: A single booster dose of the Moderna mRNA COVID-19 vaccine | Barbara Ann Karmanos Cancer Institute | NULL | Recruiting | 18 Years | N/A | All | 171 | Phase 2 | United States |
| 18 | EUCTR2021-000037-14-GR (EUCTR) | 03/08/2021 | 13/07/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 19 | EUCTR2021-000037-14-HU (EUCTR) | 08/07/2021 | 20/05/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 20 | EUCTR2021-000037-14-ES (EUCTR) | 01/07/2021 | 09/06/2021 | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, and hepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Birtamimab Product Code: Birtamimab INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid | Prothena Biosciences Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 21 | EUCTR2020-004001-32-NL (EUCTR) | 24/06/2021 | 29/01/2021 | Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | relapsed or refractory AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: belantamab mafodotin Product Code: GSK2857916 INN or Proposed INN: belantamab mafodotin | European Myeloma Network – EMN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | France;Greece;Germany;Netherlands;United Kingdom;Italy | ||
| 22 | NCT04895917 (ClinicalTrials.gov) | June 23, 2021 | 10/5/2021 | Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis | A Multi-center Open Label Phase II Study of Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis. | AL Amyloidosis | Drug: daratumumab and pomalidomide | IRCCS Policlinico S. Matteo | NULL | Recruiting | 18 Years | 99 Years | All | 40 | Phase 2 | Italy |
| 23 | NCT04924998 (ClinicalTrials.gov) | June 6, 2021 | 7/6/2021 | Clinical Study for AL-CM | Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy | Immunoglobulin Light Amyloidosis Cardiomyopathy | Drug: current treatment of AL-CM | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 18 Years | 80 Years | All | 400 | China | |
| 24 | NCT04856267 (ClinicalTrials.gov) | May 27, 2021 | 13/4/2021 | Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders | Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders | Arrythmia;Cardiac Amyloidosis;Systemic AL Amyloidosis;Sudden Cardiac Death | Device: LINQ device - implantable cardiac monitor - referred to in the application as implantable loop recorder or ILR) | Marianna Fontana | NULL | Recruiting | 18 Years | N/A | All | 100 | United Kingdom | |
| 25 | EUCTR2019-001698-10-NL (EUCTR) | 06/05/2021 | 19/03/2021 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: ION-682884 Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Israel;Chile;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;New Zealand;Japan;Sweden | ||
| 26 | EUCTR2020-004001-32-IT (EUCTR) | 03/05/2021 | 02/08/2021 | Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis. - EMN27 | Relapsed or refractory AL amyloidosis. MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belantamab mafodotin Product Code: [GSK2857916] INN or Proposed INN: belantamab mafodotin | STICHTING EUROPEAN MYELOMA NETWORK | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | France;Greece;Netherlands;Germany;United Kingdom;Italy | ||
| 27 | NCT04754945 (ClinicalTrials.gov) | April 28, 2021 | 9/2/2021 | Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis | Slow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront Therapy | AL Amyloidosis | Drug: Bortezomib;Drug: Cyclophosphamide;Drug: Dexamethasone;Biological: Isatuximab | Emory University | Sanofi;National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 25 | Phase 1 | United States |
| 28 | EUCTR2020-004001-32-DE (EUCTR) | 27/04/2021 | 04/12/2020 | Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | relapsed or refractory AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: belantamab mafodotin Product Code: GSK2857916 INN or Proposed INN: belantamab mafodotin | European Myeloma Network – EMN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | France;Greece;Netherlands;Germany;United Kingdom;Italy | ||
| 29 | NCT04270175 (ClinicalTrials.gov) | April 14, 2021 | 12/2/2020 | Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab | Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab | Amyloid;AL Amyloidosis;Refractory AL Amyloidosis | Drug: Daratumumab;Drug: Pomalidomide;Drug: Dexamethasone | Weill Medical College of Cornell University | Janssen Scientific Affairs, LLC | Recruiting | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 30 | NCT04617925 (ClinicalTrials.gov) | February 26, 2021 | 20/10/2020 | A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis | A Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis | AL Amyloidosis | Drug: Belantamab mafodotin | European Myeloma Network | GlaxoSmithKline | Recruiting | 18 Years | N/A | All | 35 | Phase 2 | United Kingdom;Netherlands;Italy;Greece;Germany;France |
| 31 | NCT04316442 (ClinicalTrials.gov) | February 25, 2021 | 16/3/2020 | Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis | A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL Amyloidosis | Light Chain (AL) Amyloidosis | Biological: STI-6129 | Sorrento Therapeutics, Inc. | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 1 | United States |
| 32 | EUCTR2019-004254-28-PL (EUCTR) | 23/02/2021 | 22/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Japan | ||
| 33 | EUCTR2020-000713-32-PL (EUCTR) | 17/02/2021 | 19/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Poland;Belgium;Australia;Germany;Japan | ||
| 34 | NCT04695340 (ClinicalTrials.gov) | February 1, 2021 | 4/1/2021 | Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis | Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis | Familial Amyloidosis | Dietary Supplement: Psyllium | Centre Hospitalier Universitaire de Nice | NULL | Not yet recruiting | 18 Years | N/A | All | 20 | N/A | France |
| 35 | EUCTR2020-004001-32-FR (EUCTR) | 29/01/2021 | 03/12/2020 | Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | relapsed or refractory AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: belantamab mafodotin Product Code: GSK2857916 INN or Proposed INN: belantamab mafodotin | European Myeloma Network – EMN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | France;Greece;Netherlands;Germany;United Kingdom;Italy | ||
| 36 | EUCTR2020-000713-32-BE (EUCTR) | 18/01/2021 | 09/11/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Greece;Spain;Israel;Russian Federation;Japan;Germany;Australia;Poland;Belgium;Canada;France;Italy;United Kingdom | ||
| 37 | JPRN-jRCT2031200299 | 15/01/2021 | 15/01/2021 | A Phase 3 Study to Evaluate the Efficacy and Safety of CAEL-101 in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIb AL Amyloidosis | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIb AL Amyloidosis | AL Amyloidosis | This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with the SoC treatment for plasma cell dyscrasia (PCD) versus placebo combined with standard of care PCD treatment in patients with Mayo stage IIIb AL amyloidosis that have not received prior treatment. Patients randomized to receive CAEL-101 will receive 1000 mg/m2. CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. Approximately 111 patients will be enrolled using a 2:1 randomization ratio. A sample size re-estimation (SSR) procedure will be performed when approximately 50% of the expected deaths has been observed. Patients in both treatment groups will be followed from randomization until death from any cause or until the end of study. | Caelum Medical Monitor | NULL | Recruiting | >= 18age old | Not applicable | Both | 3 | Phase 3 | US;UK;Australia;Canada;France;Spain;Italy;Israel;Germany;Poland;Greece;Belgium;Russia;Japan |
| 38 | JPRN-jRCT2031200300 | 15/01/2021 | 15/01/2021 | A Phase 3 Study to Evaluate the Efficacy and Safety of CAEL-101 in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIa AL Amyloidosis | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naive Patients with Mayo Stage IIIa AL Amyloidosis | AL Amyloidosis | This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with the SoC treatment for plasma cell dyscrasia (PCD) versus placebo combined with standard of care PCD treatment in patients with Mayo stage IIIa AL amyloidosis that have not received prior treatment. Patients randomized to receive CAEL-101 will receive 1000 mg/m2. CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. Approximately 267 patients will be enrolled using a 2:1 randomization ratio. A sample size re-estimation (SSR) procedure will be performed when approximately 40% of the expected deaths has been observed. Patients in both treatment groups will be followed from randomization until death from any cause or until the end of study. | Caelum Medical Monitor | NULL | Recruiting | >= 18age old | Not applicable | Both | 9 | Phase 3 | US;UK;Australia;Canada;France;Spain;Italy;Israel;Germany;Poland;Greece;Belgium;Russia;Japan |
| 39 | EUCTR2020-004001-32-GR (EUCTR) | 15/01/2021 | 04/12/2020 | Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis | relapsed or refractory AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: belantamab mafodotin Product Code: GSK2857916 INN or Proposed INN: belantamab mafodotin | European Myeloma Network – EMN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | France;Greece;Netherlands;Germany;United Kingdom;Italy | ||
| 40 | EUCTR2019-001962-13-IT (EUCTR) | 13/01/2021 | 21/10/2020 | Daratumumab and Pomalidomide in previously treated patients with AL amyloidosis | A multi-center open label phase II study of daratumumab and pomalidomide in previously treated patients with AL amyloidosis - DarP-AL | AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Imnovid Product Name: Pomalidomide Product Code: [Pomalidomide] INN or Proposed INN: pomalidomide Product Name: Daratumumab Product Code: [Daratumumab] INN or Proposed INN: DARATUMUMAB Trade Name: Imnovid Product Name: Pomalidomide Product Code: [Pomalidomide] INN or Proposed INN: Pomalidomide Trade Name: Imnovid Product Name: Pomalidomide Product Code: [Pomalidomide] INN or Proposed INN: pomalidomide | FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Italy | ||
| 41 | EUCTR2019-004254-28-FR (EUCTR) | 07/01/2021 | 04/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 42 | EUCTR2019-004254-28-BE (EUCTR) | 04/01/2021 | 05/11/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 43 | EUCTR2020-000713-32-DE (EUCTR) | 23/12/2020 | 09/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 44 | EUCTR2019-004254-28-DE (EUCTR) | 23/12/2020 | 09/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 45 | EUCTR2019-004254-28-GB (EUCTR) | 30/11/2020 | 10/09/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | Stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4 | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 46 | EUCTR2020-000713-32-GR (EUCTR) | 27/11/2020 | 05/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | stage IIIa cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 267 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 47 | EUCTR2019-004254-28-GR (EUCTR) | 27/11/2020 | 05/10/2020 | A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis. | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | stage IIIb cardiac AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10007509;Term: Cardiac amyloidosis;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CAEL-101 INN or Proposed INN: Not assigned Other descriptive name: Ch11-1F4 (NSC-711516) | Caelum Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 111 | Phase 3 | United States;Greece;Spain;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan | ||
| 48 | EUCTR2018-004670-10-BG (EUCTR) | 25/11/2020 | 04/08/2020 | Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN) MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AG10 Product Code: AG10 HCl INN or Proposed INN: AG10 HCl Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID | Eidos Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands;New Zealand | ||
| 49 | NCT04601051 (ClinicalTrials.gov) | November 5, 2020 | 19/10/2020 | Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2001 in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (ATTRv-PN) and Patients With Transthyretin Amyloidosis-Related Cardiomyopathy (ATTR-CM) | Phase 1 Two-Part (Open-label, Single Ascending Dose (Part 1) and Open-label, Single Dose Expansion (Part 2)) Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2001 in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (ATTRv-PN) and Patients With Transthyretin Amyloidosis-Related Cardiomyopathy (ATTR-CM) | Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy;Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy;Wild-Type Transthyretin Cardiac Amyloidosis | Biological: NTLA-2001 | Intellia Therapeutics | NULL | Recruiting | 18 Years | 90 Years | All | 74 | Phase 1 | New Zealand;Sweden;United Kingdom |
| 50 | NCT04418024 (ClinicalTrials.gov) | October 21, 2020 | 22/5/2020 | Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Polyneurophathy | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) | Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy | Drug: AG10;Drug: Placebo | Eidos Therapeutics, a BridgeBio company | NULL | Withdrawn | 18 Years | 90 Years | All | 0 | Phase 3 | United States;Canada;Spain |
| 51 | EUCTR2018-004670-10-FR (EUCTR) | 29/09/2020 | 05/06/2020 | Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN) MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AG10 Product Code: AG10 HCl INN or Proposed INN: AG10 HCl Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID | Eidos Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands;New Zealand | ||
| 52 | EUCTR2018-004670-10-DE (EUCTR) | 28/09/2020 | 25/05/2020 | Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN) MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AG10 Product Code: AG10 HCl INN or Proposed INN: AG10 HCl Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID | Eidos Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands;New Zealand | ||
| 53 | EUCTR2019-001698-10-CY (EUCTR) | 24/09/2020 | 11/09/2020 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: ION-682884 Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Latvia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden | ||
| 54 | EUCTR2018-004670-10-PT (EUCTR) | 31/08/2020 | 04/06/2020 | Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN) MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AG10 Product Code: AG10 HCl INN or Proposed INN: AG10 HCl Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID | Eidos Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Phase 3 | Portugal;New Zealand;Taiwan;Turkey;Russian Federation;Spain;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands | ||
| 55 | NCT04504825 (ClinicalTrials.gov) | August 25, 2020 | 20/7/2020 | A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen | Caelum Biosciences, Inc. | Alexion Pharmaceuticals | Recruiting | 18 Years | N/A | All | 111 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom |
| 56 | NCT04512235 (ClinicalTrials.gov) | August 25, 2020 | 10/8/2020 | A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen | Caelum Biosciences, Inc. | Alexion Pharmaceuticals | Recruiting | 18 Years | N/A | All | 267 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom |
| 57 | NCT04115956 (ClinicalTrials.gov) | August 6, 2020 | 29/8/2019 | A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy | AL Amyloidosis | Drug: Melphalan-Flufenamide (Melflufen);Drug: Dexamethasone | Oncopeptides AB | PRA Health Sciences | Terminated | 18 Years | N/A | All | 6 | Phase 1/Phase 2 | United States;Czechia;France;Germany;Greece;Israel;Norway;Spain;United Kingdom;Italy;Poland |
| 58 | EUCTR2018-004670-10-IT (EUCTR) | 24/07/2020 | 24/05/2021 | Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN) MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AG10 Product Code: [AG10 HCl] INN or Proposed INN: AG10 HCl Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID | Eidos Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Germany;Netherlands;New Zealand | ||
| 59 | NCT04392960 (ClinicalTrials.gov) | July 22, 2020 | 27/2/2020 | Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis | Molecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL Amyloidosis | AL Amyloidosis | Drug: [18F]Florbetaben | IRCCS Policlinico S. Matteo | NULL | Recruiting | 18 Years | N/A | All | 69 | N/A | Italy |
| 60 | EUCTR2019-001698-10-GR (EUCTR) | 17/07/2020 | 11/06/2020 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: ION-682884 Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Greece;Spain;Ireland;Turkey;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Cyprus;Australia;Netherlands;Germany;Japan;New Zealand;Sweden | ||
| 61 | EUCTR2018-004670-10-HU (EUCTR) | 07/07/2020 | 12/05/2020 | Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN) MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AG10 Product Code: AG10 HCl INN or Proposed INN: AG10 HCl Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID | Eidos Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands;New Zealand | ||
| 62 | EUCTR2019-001698-10-SE (EUCTR) | 13/05/2020 | 24/02/2020 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Greece;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Netherlands;Germany;New Zealand;Sweden | ||
| 63 | EUCTR2019-001698-10-DE (EUCTR) | 29/03/2020 | 24/10/2019 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: Eplontersen Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Greece;Spain;Turkey;United Kingdom;Italy;France;Canada;Argentina;Brazil;Cyprus;Australia;Netherlands;Germany;New Zealand;Sweden | ||
| 64 | EUCTR2019-001698-10-PT (EUCTR) | 19/03/2020 | 18/10/2019 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: ION-682884 Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Spain;Ireland;Chile;Switzerland;Italy;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden;Israel;France;Estonia;Greece;Canada | ||
| 65 | NCT04304144 (ClinicalTrials.gov) | March 18, 2020 | 28/2/2020 | A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis | CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis | AL Amyloidosis | Drug: CAEL-101;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: Daratumumab | Caelum Biosciences | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 66 | EUCTR2018-002761-19-DE (EUCTR) | 06/03/2020 | 12/08/2019 | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 67 | EUCTR2019-001698-10-GB (EUCTR) | 06/03/2020 | 18/10/2019 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: ION-682884 Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden | ||
| 68 | EUCTR2019-001698-10-IT (EUCTR) | 27/02/2020 | 03/12/2019 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: ION-682884 Other descriptive name: ION-682884 Product Name: inotersen Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Latvia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden | ||
| 69 | EUCTR2019-001698-10-ES (EUCTR) | 14/02/2020 | 02/12/2019 | Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy | A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM | Hereditary Transthyretin-Mediated Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ION-682884 Product Code: ION-682884 INN or Proposed INN: ION-682884 Other descriptive name: ION-682884 Product Name: Inoserten Product Code: ISIS 420915 INN or Proposed INN: INOTERSEN | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;Latvia;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;New Zealand;Japan | ||
| 70 | EUCTR2018-002761-19-ES (EUCTR) | 05/02/2020 | 09/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis.Patients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy | ||
| 71 | EUCTR2018-004333-33-FR (EUCTR) | 23/01/2020 | 02/12/2019 | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 INN or Proposed INN: Recombinant human hyaluronidase PH20 Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20 | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;Greece;Netherlands;Italy | ||
| 72 | NCT04612582 (ClinicalTrials.gov) | January 1, 2020 | 15/6/2020 | Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis | A Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial(BTD-CHINA-TRIAL) | Immunoglobulin Light-Chain Amyloidosis | Drug: Thalidomide;Drug: Cyclophosphamide | Guangdong Provincial People's Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 70 | Phase 4 | China |
| 73 | EUCTR2018-002761-19-GR (EUCTR) | 03/12/2019 | 15/11/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 74 | EUCTR2018-002761-19-NO (EUCTR) | 15/11/2019 | 01/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy | ||
| 75 | EUCTR2018-002761-19-IT (EUCTR) | 25/10/2019 | 29/01/2021 | It is an early clinical trial to assess a new drug (Melflufen) when given together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis. Patients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy - NA | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen Product Code: [Melflufen] INN or Proposed INN: melphalan fulfenamide hydrochloride Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: [H02AB02] INN or Proposed INN: DESAMETASONE | ONCOPEPTIDES AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 1;Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 76 | EUCTR2018-002761-19-PL (EUCTR) | 24/10/2019 | 07/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | Italy;United Kingdom;Germany;Norway;Israel;Poland;Spain;Greece;Czech Republic;Czechia;United States;France | ||
| 77 | EUCTR2018-002761-19-CZ (EUCTR) | 21/10/2019 | 31/07/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom | ||
| 78 | EUCTR2018-004333-33-IT (EUCTR) | 01/08/2019 | 28/04/2020 | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis - EMN22/54767414AMY2005 | Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMUMAB Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 INN or Proposed INN: Recombinant human hyaluronidase PH20 Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20 Product Name: Decadron Product Code: H02AB02 Desametasone INN or Proposed INN: DEXAMETHASONE Other descriptive name: Dexamethasone | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;Greece;Netherlands;Italy | ||
| 79 | EUCTR2018-004333-33-NL (EUCTR) | 24/07/2019 | 08/07/2019 | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMUMAB Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 INN or Proposed INN: Recombinant human hyaluronidase PH20 Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20 | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;Greece;Netherlands;Italy | ||
| 80 | EUCTR2018-004333-33-GR (EUCTR) | 08/07/2019 | 05/06/2019 | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMUMAB Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 INN or Proposed INN: Recombinant human hyaluronidase PH20 Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20 | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;Greece;Netherlands;Italy | ||
| 81 | EUCTR2017-002210-31-DE (EUCTR) | 31/05/2019 | 24/01/2019 | An allocation by random phase II/III trial of doxycycline in comparison to standard therapy in newly-diagnosed cardiac AL amyloidosis patients with bortezomib-based therapy | A randomized phase II/III trial of doxycycline vs. standard supportive therapy in newly-diagnosed cardiac AL amyloidosis patients undergoing bortezomib-based therapy - ReDox | Light chain (AL) amyloidosis is a protein conformational disease, caused by a small bone marrow plasma cell clone producing light chains (LCs) that undergo conformational changes, aggregate and deposit in tissues in the form of amyloid fibrils. This process causes dysfunction of the organs involved and leads to death if not effectively treated.;Therapeutic area: Not possible to specify | Trade Name: DoxyHEXAL® tabs 100 mg Tabletten Product Name: DoxyHEXAL® tabs 100 mg Tabletten INN or Proposed INN: DOXYCYCLINE | Amyloid Center - Biotechnology Research Laboratories Policlinico San Matteo | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Canada;Turkey;Germany | ||
| 82 | NCT04298372 (ClinicalTrials.gov) | February 20, 2019 | 3/12/2019 | Frontline Lenalidomide for AL Amyloidosis Involving Myocardium | Frontline Lenalidomide for AL Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of Lenalidomide | Amyloidosis Cardiac | Drug: Lenalidomide 25mg | Seoul National University Hospital | NULL | Recruiting | 19 Years | 99 Years | All | 30 | Phase 3 | Korea, Republic of |
| 83 | NCT03474458 (ClinicalTrials.gov) | February 11, 2019 | 16/3/2018 | A Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy | A Randomized Phase II/III Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy | Cardiac AL Amyloidosis | Drug: Doxycycline;Drug: Standard of care therapy | IRCCS Policlinico S. Matteo | NULL | Recruiting | 18 Years | N/A | All | 120 | Phase 2/Phase 3 | Canada;France;Germany;Greece;Italy;Spain;Turkey;United Kingdom |
| 84 | EUCTR2016-001737-27-GB (EUCTR) | 08/10/2018 | 11/01/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 85 | NCT03678259 (ClinicalTrials.gov) | October 1, 2018 | 30/7/2018 | 124I-p5+14 Injection Safety in Subjects With Systemic Amyloidosis | Evaluation of 124I-p5+14 Injection as an Imaging Agent for the Detection of Systemic Amyloidosis | Systemic Amyloidosis | Drug: 124I-p5+14 Injection | University of Tennessee Graduate School of Medicine | NULL | Active, not recruiting | 18 Years | N/A | All | 57 | Phase 1/Phase 2 | United States |
| 86 | EUCTR2016-001737-27-PL (EUCTR) | 06/09/2018 | 16/07/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | Sweden;Korea, Republic of;China;Japan;Germany;Netherlands;Denmark;Australia;Romania;Brazil;Belgium;Poland;Canada;Mexico;Hungary;France;United Kingdom;Italy;Israel;Turkey;Spain;Greece;United States | ||
| 87 | EUCTR2016-001737-27-DK (EUCTR) | 22/08/2018 | 04/06/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Australia;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 88 | NCT03618537 (ClinicalTrials.gov) | August 2, 2018 | 2/8/2018 | Ixazomib Maintenance Study in Patients With AL Amyloidosis | Ixazomib Maintenance Following Initial Therapy in Patients With Immunoglobulin Light Chain (AL) Amyloidosis | AL Amyloidosis | Drug: Ixazomib;Drug: Dexamethasone | Memorial Sloan Kettering Cancer Center | Tufts Medical Center;Vanderbilt University Medical Center | Recruiting | 18 Years | N/A | All | 47 | Phase 2 | United States |
| 89 | JPRN-JapicCTI-183929 | 17/7/2018 | 13/04/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | Amyloidosis | Intervention name : Cyclophosphamide, Bortezomib, dexamethasone plus Daratumumab INN of the intervention : - Dosage And administration of the intervention : Participants will receive dexamethasone (20mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years. Control intervention name : Cyclophosphamide, Bortezomib, dexamethasone INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive dexamethasone (40milligrams [mg] orally or intravenous [IV]dose), followed by cyclophosphamide (300milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. | Janssen Pharmaceutical K.K. | NULL | complete | 20 | BOTH | 370 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 90 | EUCTR2016-001737-27-SE (EUCTR) | 07/05/2018 | 20/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 91 | EUCTR2017-005115-13-ES (EUCTR) | 25/04/2018 | 19/02/2018 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 164 | Phase 3 | United Kingdom;New Zealand;Italy;Portugal;France;United States;Argentina;Brazil;Spain;Germany | ||
| 92 | EUCTR2017-005115-13-PT (EUCTR) | 23/04/2018 | 06/03/2018 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 Other descriptive name: Inotersen | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 164 | Phase 3 | France;United States;Portugal;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom | ||
| 93 | EUCTR2016-001737-27-GR (EUCTR) | 16/04/2018 | 22/03/2018 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 94 | EUCTR2016-001737-27-DE (EUCTR) | 16/04/2018 | 16/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 95 | NCT03130348 (ClinicalTrials.gov) | March 15, 2018 | 21/4/2017 | Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain Amyloidosis | Phase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain Amyloidosis | Amyloidosis;Immunoglobulin Light Chain Deposition | Drug: Bortezomib;Drug: Dexamethasone;Drug: Ibrutinib;Other: Laboratory Biomarker Analysis | Mayo Clinic | National Cancer Institute (NCI) | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 96 | EUCTR2016-001737-27-NL (EUCTR) | 15/03/2018 | 29/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of;Sweden | ||
| 97 | NCT03499808 (ClinicalTrials.gov) | March 8, 2018 | 9/4/2018 | S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis | A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis | Amorphous, Eosinophilic, and Acellular Deposit;Constipation;Diarrhea;Early Satiety;Gastrointestinal Hemorrhage;Hepatomegaly;Lymphadenopathy;Macroglossia;Nausea;Primary Systemic Amyloidosis;Purpura;Recurrent Primary Amyloidosis;Refractory Primary Amyloidosis | Biological: Isatuximab;Other: Laboratory Biomarker Analysis | Southwest Oncology Group | National Cancer Institute (NCI) | Active, not recruiting | 18 Years | N/A | All | 43 | Phase 2 | United States |
| 98 | EUCTR2016-001737-27-IT (EUCTR) | 01/03/2018 | 17/06/2021 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis - ANDROMEDA | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: daratumumab coformulato con ialuronidasi umana ricombinante (rHuPH20) Product Code: [JnJ 54767414] INN or Proposed INN: Daratumumab Other descriptive name: HUMAX-CD38 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 99 | EUCTR2016-004664-18-DE (EUCTR) | 09/02/2018 | 24/05/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 100 | NCT03283917 (ClinicalTrials.gov) | February 7, 2018 | 13/9/2017 | Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis | A Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis | Newly Diagnosed Primary Amyloidosis;Recurrent Primary Amyloidosis;Refractory Primary Amyloidosis | Biological: Daratumumab;Drug: Dexamethasone;Drug: Ixazomib | M.D. Anderson Cancer Center | Janssen Pharmaceuticals;Takeda Pharmaceutical | Recruiting | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 101 | EUCTR2016-001737-27-ES (EUCTR) | 06/02/2018 | 23/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 102 | EUCTR2016-001737-27-HU (EUCTR) | 25/01/2018 | 28/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 103 | EUCTR2016-001737-27-BE (EUCTR) | 16/01/2018 | 16/11/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20) Product Code: JnJ 54767414 INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||
| 104 | NCT02994784 (ClinicalTrials.gov) | January 8, 2018 | 18/11/2016 | Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients | A Phase II Single-Center, Open-Label, Safety and Efficacy Study of Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients Undergoing Autologous Stem Cell Transplantation | Amyloidosis; Systemic | Drug: Propylene Glycol-Free Melphalan Hydrochloride | Boston Medical Center | Spectrum Pharmaceuticals, Inc | Recruiting | 18 Years | N/A | All | 43 | Phase 2 | United States |
| 105 | NCT03315026 (ClinicalTrials.gov) | December 14, 2017 | 13/10/2017 | Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis | Phase II Study of Interleukin 6 Blockade With Siltuximab to Decrease Symptom Burden in Patients Age 60-75 Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma and AL Amyloidosis | Multiple Myeloma;AL Amyloidosis | Drug: Siltuximab;Behavioral: The M.D. Anderson Symptom Inventory (MDASI) | Memorial Sloan Kettering Cancer Center | Janssen Scientific Affairs, LLC | Active, not recruiting | 60 Years | 75 Years | All | 30 | Phase 2 | United States |
| 106 | EUCTR2016-004664-18-AT (EUCTR) | 07/11/2017 | 20/09/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;Australia;Austria;Israel;Germany;Italy;United Kingdom;United States;Greece;Spain | ||
| 107 | EUCTR2016-000287-42-IT (EUCTR) | 18/10/2017 | 05/01/2021 | A Multicentre Open label Phase II study of Daratumumab in AL Amyloidosis in patients not in VGPR or Better - AMYDARA | A Multicentre Open label Phase II study of Daratumumab in AL Amyloidosis in patients not in VGPR or Better - AMYDARA | AL amyloidosis MedDRA version: 20.0;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: HuMax-CD38 Product Code: NA INN or Proposed INN: Daratumumab | CHU DE LIMOGES | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Italy | ||
| 108 | NCT03201965 (ClinicalTrials.gov) | October 5, 2017 | 27/6/2017 | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis | Amyloidosis | Drug: Cyclophosphamide;Drug: Bortezomib;Drug: Dexamethasone, 40 mg;Drug: Daratumumab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 18 Years | N/A | All | 416 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;China;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;United Kingdom;Romania |
| 109 | EUCTR2016-000489-50-IT (EUCTR) | 03/10/2017 | 08/06/2021 | Evaluation of efficacy and safety of NEOD001 in subjects with light chain (AL) amyloidosis with hepatic involvement | A Phase II, Single Arm, Open Label, Efficacy and Safety Study of NEOD001 in Subjects with Light Chain (AL) Amyloidosis with Hepatic Involvement - --- | AL amyloidosis with hepatic involvement MedDRA version: 20.0;Level: PT;Classification code 10075251;Term: Hepatic amyloidosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 Product Code: NEOD001 Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 2 | Italy | ||
| 110 | ChiCTR-IPR-17012637 | 2017-10-01 | 2017-09-11 | Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis | Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis | type AL amyloidosis | Group 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD); | Guangdong General Hospital | NULL | Pending | 18 | 75 | Both | Group 1:35;Group 2:35; | China | |
| 111 | EUCTR2016-004664-18-GR (EUCTR) | 27/09/2017 | 02/06/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 112 | NCT03252600 (ClinicalTrials.gov) | August 25, 2017 | 24/7/2017 | Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary Amyloidosis | A Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL Amyloidosis | Recurrent Primary Amyloidosis | Drug: Cyclophosphamide;Drug: Dexamethasone;Biological: Elotuzumab;Other: Laboratory Biomarker Analysis;Drug: Lenalidomide;Other: Pharmacological Study | Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI);Bristol-Myers Squibb;Multiple Myeloma Research Consortium | Active, not recruiting | 18 Years | N/A | All | 53 | Phase 2 | United States |
| 113 | EUCTR2016-004664-18-GB (EUCTR) | 08/08/2017 | 09/05/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 114 | EUCTR2016-004664-18-ES (EUCTR) | 31/07/2017 | 29/05/2017 | A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) | The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201 MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 115 | NCT03154047 (ClinicalTrials.gov) | June 14, 2017 | 28/4/2017 | Study in Subjects With Light Chain (AL) Amyloidosis | A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO) | AL Amyloidosis | Drug: NEOD001 | Prothena Therapeutics Ltd. | NULL | Terminated | 18 Years | N/A | All | 80 | Phase 2 | United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom |
| 116 | NCT03236792 (ClinicalTrials.gov) | June 12, 2017 | 20/7/2017 | Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis | Phase 1/2 Study Of Ixazomib In Combination With Cyclophosphamide And Dexamethasone In Patients With Newly Diagnosed Immunoglobulin Light Chain AL Amyloidosis | AL Amyloidosis | Drug: Ixazomib;Drug: Cyclophosphamide;Drug: Dexamethasone | Icahn School of Medicine at Mount Sinai | Millennium Pharmaceuticals, Inc. | Recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
| 117 | NCT02841033 (ClinicalTrials.gov) | March 20, 2017 | 14/6/2016 | Daratumumab for the Treatment of Patients With AL Amyloidosis | A Phase I-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis | AL Amyloidosis | Drug: daratumumab | Boston Medical Center | Janssen Pharmaceuticals | Completed | 18 Years | N/A | All | 25 | Phase 1/Phase 2 | United States |
| 118 | NCT03000660 (ClinicalTrials.gov) | January 2017 | 12/12/2016 | Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis | A Phase I Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis | AL Amyloidosis | Drug: Venetoclax;Drug: Dexamethasone | Tufts Medical Center | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 1 | United States |
| 119 | EUCTR2016-000276-23-GB (EUCTR) | 06/12/2016 | 11/07/2016 | Study to look at the affect of anti-SAP treatment in patients with cardiac amyloidosis | A multiple treatment session, open label phase 2 clinical study of GSK2398852 administered following and together with GSK2315698 in cohorts of patients with cardiac amyloidosis | Systemic amyloidosis MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GSK2315698 Product Code: GSK2315698 INN or Proposed INN: miridesap Other descriptive name: CPHC (carboxy pyrrolidine hexanoyl pyrrolidone carboxylate) Product Name: GSK2398852 Product Code: GSK2398852 INN or Proposed INN: dezamizumab | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;United Kingdom | ||
| 120 | NCT02816476 (ClinicalTrials.gov) | September 2016 | 22/6/2016 | Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis | A Multicentre Open Label Phase II Study of Daratumumab in AL Amyloidosis Patients Not in VGPR or Better | Amyloidosis | Drug: Daratumumab | University Hospital, Limoges | NULL | Completed | 18 Years | N/A | All | 40 | Phase 2 | France;Italy |
| 121 | EUCTR2015-004318-14-AT (EUCTR) | 07/07/2016 | 22/08/2016 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 2 | France;United States;Greece;Spain;Australia;Austria;Israel;Germany;Italy;United Kingdom | ||
| 122 | EUCTR2015-005333-49-GB (EUCTR) | 30/06/2016 | 04/04/2016 | A study to look at the long-term efficacy and safety of ALN-TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Multicenter, Multinational, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Revusiran in Patients with Transthyretin-mediated Familial Amyloidotic Cardiomyopathy | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Revusiran Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Mexico;Canada;Spain;Brazil;Belgium;Germany;Italy;United Kingdom;Sweden | ||
| 123 | EUCTR2015-004318-14-DE (EUCTR) | 13/06/2016 | 26/11/2015 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 2 | United States;France;Greece;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy | ||
| 124 | EUCTR2016-000287-42-FR (EUCTR) | 18/05/2016 | 08/06/2016 | Amyloidosis Patients traitment | A Multicentre Open label Phase II study of Daratumumab in AL AmyloidosisPatients not in VGPR or Better - AMYDARA | AL Amyloidosis MedDRA version: 19.0;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Product Name: HuMax-CD38 INN or Proposed INN: DARATUMUMAB | CHU de Limoges | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France | ||
| 125 | NCT02603172 (ClinicalTrials.gov) | May 12, 2016 | 9/11/2015 | A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis | A Three-part Open-label, Non-randomised, Dose-escalation Study to Investigate the Safety and Tolerability of GSK3039294 Administered as a Single Dose to Healthy Volunteers, and as Repeat Dose to Healthy Volunteers and Patients With Systemic Amyloidosis | Amyloidosis | Drug: GSK3039294 | GlaxoSmithKline | NULL | Terminated | 18 Years | 70 Years | All | 23 | Phase 1 | United Kingdom |
| 126 | ChiCTR-IPR-16008422 | 2016-05-05 | 2016-05-08 | Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL) | Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL) | primary systemic amyloidosis (AL) | the first group: the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD);the second group:the combination regimen of bortezomib +thalidomide + dexamethasone (BTD) ; | People's Hospital, Beijing University | NULL | Recruiting | 18 | 75 | Both | the first group:60;the second group:60; | China | |
| 127 | EUCTR2015-004318-14-GR (EUCTR) | 21/04/2016 | 11/02/2016 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 128 | EUCTR2015-004318-14-ES (EUCTR) | 10/03/2016 | 18/03/2016 | A study is to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis or primary systemic amyloidosis, involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains by plasma cells results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs of individuals with AL amyloidosis. MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 129 | NCT02632786 (ClinicalTrials.gov) | March 2016 | 9/12/2015 | The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction | AL Amyloidosis | Drug: NEOD001;Drug: Placebo | Prothena Therapeutics Ltd. | NULL | Completed | 18 Years | N/A | All | 129 | Phase 2 | United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom |
| 130 | EUCTR2015-004318-14-GB (EUCTR) | 05/02/2016 | 27/11/2015 | A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction | Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NEOD001 INN or Proposed INN: N/A Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody | Prothena Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 2 | United States;France;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom | ||
| 131 | NCT02613182 (ClinicalTrials.gov) | February 2016 | 18/11/2015 | Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis | Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) Amyloidosis | AL Amyloidosis | Drug: NEOD001 | Prothena Therapeutics Ltd. | NULL | Terminated | N/A | N/A | All | 34 | Phase 2 | United States |
| 132 | NCT02627820 (ClinicalTrials.gov) | January 2016 | 19/11/2015 | The Effect of an Antisense Oligonucleotide to Lower Transthyretin (TTR) Levels on the Progression of -Wild-type TTR Involving the Heart | An 18 Month Open Label Study Of The Tolerability And Efficacy Of An Antisense Oligonucleotide In Patients With Wild-Type Transthyretin Amyloid Cardiomyopathy (Senile Systemic Amyloidosis) | Amyloidosis | Drug: Isis 420915/GSK 299872 | Brigham and Women's Hospital | GlaxoSmithKline;Ionis Pharmaceuticals, Inc. | Withdrawn | 50 Years | 90 Years | Both | 0 | Phase 2 | NULL |
| 133 | EUCTR2013-004561-13-ES (EUCTR) | 28/12/2015 | 30/10/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 18.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | |||
| 134 | EUCTR2015-002231-18-GB (EUCTR) | 01/12/2015 | 23/09/2015 | A Phase I/IIa (early phase) Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis | A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis - Targeted Radiotherapy for AL-Amyloidosis –‘TRALA’ | AL-Amyloidosis MedDRA version: 18.0;Level: LLT;Classification code 10024460;Term: Light chain disease myeloma associated;System Organ Class: 100000004864;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: CHX-A-DTPA-Anti-CD66 INN or Proposed INN: CHX A-DTPA anti-CD66 antibody Product Name: Indium 111 labelled Anti-CD66 INN or Proposed INN: Indium 111-radiolabelled anti-CD66 Product Name: yttrium-90 radiolabelled anti-CD66 antibody INN or Proposed INN: Yttrium90 radiolabelled antiCD66 | University Southampton Hospital NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 1/2 | United Kingdom | ||
| 135 | NCT02545907 (ClinicalTrials.gov) | October 2015 | 27/8/2015 | A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis | A Single Arm Open Labeled Multicentre Phase 1b Dose Escalation Study of Carfilzomib Taken in Combination With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis | Amyloidosis | Drug: Carfilzomib;Drug: Thalidomide;Drug: Dexamethasone | University College, London | NULL | Not yet recruiting | 18 Years | N/A | Both | 36 | Phase 1/Phase 2 | United Kingdom |
| 136 | EUCTR2013-004561-13-DE (EUCTR) | 22/09/2015 | 15/06/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 3 | Portugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom | ||
| 137 | EUCTR2013-004561-13-GB (EUCTR) | 23/07/2015 | 09/02/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 19.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 3 | Portugal;France;United States;Argentina;Brazil;Spain;Germany;Italy;United Kingdom | ||
| 138 | EUCTR2014-003835-20-DE (EUCTR) | 24/06/2015 | 02/12/2014 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 19.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden | ||
| 139 | NCT02489500 (ClinicalTrials.gov) | June 2015 | 9/3/2015 | Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib | Phase III Trial of High-dose Melphalan and Stem Cell Transplantation Versus High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis | AL Amyloidosis | Drug: Bortezomib;Drug: Melphalan;Drug: Neupogen;Procedure: Stem Cell Collection;Procedure: Stem cell infusion | Boston Medical Center | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 3 | United States |
| 140 | EUCTR2014-003835-20-SE (EUCTR) | 20/05/2015 | 27/11/2014 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 19.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden | ||
| 141 | EUCTR2014-003835-20-IT (EUCTR) | 05/05/2015 | 09/03/2016 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) - na | Trasthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 20.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC | ALNYLAM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Canada;Spain;Brazil;Belgium;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 142 | EUCTR2012-001831-30-BG (EUCTR) | 23/04/2015 | 23/02/2015 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 18.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2/3 | Portugal;France;United States;Mexico;Argentina;Brazil;Spain;Australia;Bulgaria;Germany;Italy;United Kingdom | ||
| 143 | JPRN-UMIN000019732 | 2015/03/31 | 11/11/2015 | A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract. | ligh chain amyloidosis | standerd therapy plus the high dose green tea therapy. Drug: green tea extract powder Pharmaceutical formulation: capsules dose 2400 mg/d p.o. for 6 months every day standerd therapy | Japanese Red Cross Medical Center, Division of Hematology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Phase 2 | Japan | |
| 144 | EUCTR2014-003835-20-ES (EUCTR) | 30/03/2015 | 14/01/2015 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.0;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: NA Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Brazil;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 145 | EUCTR2014-003835-20-BE (EUCTR) | 25/03/2015 | 03/02/2015 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Mexico;Canada;Brazil;Spain;Belgium;Germany;Italy;United Kingdom;Sweden | ||
| 146 | NCT02312206 (ClinicalTrials.gov) | February 2015 | 2/12/2014 | The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis | Primary Systemic (AL) Amyloidosis | Drug: NEOD001;Other: Placebo | Prothena Therapeutics Ltd. | NULL | Terminated | 18 Years | N/A | All | 260 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |
| 147 | NCT01531751 (ClinicalTrials.gov) | February 2015 | 11/1/2012 | High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease | An Open Label Phase II Trial of Free Light Chain Removal by Extended High Cut-Off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End-Stage Renal Disease. | Primary Amyloidosis of Light Chain Type | Device: High Cut-off Hemodialysis;Drug: Chemotherapy | IRCCS Policlinico S. Matteo | NULL | Withdrawn | 18 Years | N/A | Female | 0 | Phase 2 | Italy |
| 148 | NCT02245867 (ClinicalTrials.gov) | December 2, 2014 | 15/9/2014 | Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis | Phase Ia/Ib Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis | Amyloidosis | Drug: Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4 | Andrew Eisenberger | NULL | Completed | 21 Years | N/A | All | 31 | Phase 1 | United States |
| 149 | EUCTR2014-003835-20-GB (EUCTR) | 26/11/2014 | 17/10/2014 | A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart. | A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) | Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC) MedDRA version: 18.1;Level: PT;Classification code 10016202;Term: Familial amyloidosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ALN-TTRSC Product Code: ALN-TTRSC INN or Proposed INN: Revusiran Other descriptive name: ALN-51547 | Alnylam Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Brazil;Belgium;Spain;Germany;Italy;France;United States;Canada;United Kingdom;Sweden | ||
| 150 | NCT02207556 (ClinicalTrials.gov) | October 1, 2014 | 23/7/2014 | Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial | Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis (DUAL) Trial: A Phase II Open Label Study of Oral Doxycycline Administered as an Adjunct to Plasma Cell Directed Therapy in Light Chain (AL) Amyloidosis | Primary Systemic Amyloidosis | Drug: Doxycycline | Medical College of Wisconsin | NULL | Active, not recruiting | 18 Years | N/A | All | 32 | Phase 2 | United States |
| 151 | EUCTR2014-001586-27-ES (EUCTR) | 25/07/2014 | 02/06/2014 | Study of SOM0226 in familial amyloid polyneuropathy (FAP) patients and asymptomatic carriers to evaluate protein stabilization activity | Study of SOM0226 in familial amyloid polyneuropathy (FAP) patients and asymptomatic carriers to evaluate protein stabilization activity | Patients with familial amyloid polyneuropathy (FAP), asymptomatic carriers and healthy volunteers MedDRA version: 17.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tasmar INN or Proposed INN: TOLCAPONE | SOM Innovation Biotech SL (SOM Biotech) | NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
| 152 | EUCTR2013-004561-13-PT (EUCTR) | 04/07/2014 | 07/05/2014 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 3 | United States;France;Portugal;Argentina;Spain;Brazil;Germany;United Kingdom;New Zealand;Italy | ||
| 153 | NCT02191826 (ClinicalTrials.gov) | July 2014 | 9/7/2014 | Study of SOM0226 in Familial Amyloid Polyneuropathy | Study of SOM0226 in Familial Amyloid Polyneuropathy (FAP) Patients and Asymptomatic Carriers to Evaluate Protein Stabilization Activity | Familial Amyloid Polyneuropathy (FAP) | Drug: SOM0226 | SOM Biotech SL | Hospital Vall d'Hebron | Completed | 18 Years | N/A | Both | 17 | Phase 1/Phase 2 | Spain |
| 154 | NCT02175004 (ClinicalTrials.gov) | June 2014 | 12/6/2014 | Open-Label Extension Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP) | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP) | FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;Amyloidosis | Drug: IONIS-TTR Rx | Ionis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 135 | Phase 3 | United States;Argentina;Brazil;France;Germany;Italy;Portugal;Spain;United Kingdom;New Zealand |
| 155 | EUCTR2012-001831-30-ES (EUCTR) | 25/04/2014 | 07/03/2014 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 16.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2;Phase 3 | United States;France;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;United Kingdom;Italy | ||
| 156 | EUCTR2013-004561-13-FR (EUCTR) | 16/04/2014 | 17/06/2015 | Not available | An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 18.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 3 | United States;Portugal;France;Argentina;Spain;Brazil;Germany;United Kingdom;Italy | ||
| 157 | NCT01807286 (ClinicalTrials.gov) | January 2014 | 6/3/2013 | Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis | A Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase I | Myeloma | Drug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: Questionnaires | M.D. Anderson Cancer Center | Celgene | Terminated | 18 Years | N/A | Both | 3 | Phase 1 | United States |
| 158 | EUCTR2010-022395-31-CZ (EUCTR) | 01/10/2013 | 17/07/2013 | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. | AL Amyloidosis MedDRA version: 16.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VELCADE INN or Proposed INN: BORTEZOMIB Trade Name: ALKERAN Product Name: Melphalan INN or Proposed INN: MELPHALAN Trade Name: FORTECORTIN Product Name: dexamethasone Product Code: A01AC02 INN or Proposed INN: DEXAMETHASONE | E.M.N. - EUROPEAN MYELOMA NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 159 | JPRN-UMIN000012319 | 2013/09/15 | 25/11/2013 | Imaging of systemic amyloidosis with 99mTc-aprotinin | Cardiac amyloidosis | Whole-body and cross sectional images will be obtained using a SPECT camera 90min after injection of 740MBq of 99mTc-aprotinin.Biopsy will be planned for the positive patients to confirm the image diagnosis. | National Center for Global Health and Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 80 | Not selected | Japan | |
| 160 | EUCTR2012-001831-30-DE (EUCTR) | 22/08/2013 | 29/05/2013 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 19.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | ||
| 161 | EUCTR2012-001831-30-IT (EUCTR) | 04/07/2013 | 19/06/2013 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2;Phase 3 | France;United States;Portugal;Spain;Brazil;Bulgaria;Germany;United Kingdom;Italy | ||
| 162 | NCT01777243 (ClinicalTrials.gov) | May 13, 2013 | 24/1/2013 | A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis | A Single Dose First in Human Study of GSK2398852 Co-Administered With GSK2315698 in Patients With Systemic Amyloidosis | Amyloidosis | Drug: GSK2398852;Drug: GSK2315698 | GlaxoSmithKline | Imperial College London;Heart Hospital;Royal Free Hospital NHS Foundation Trust;Quintiles, Inc. | Completed | 18 Years | 70 Years | All | 25 | Phase 1 | United Kingdom |
| 163 | EUCTR2012-001831-30-GB (EUCTR) | 22/04/2013 | 16/11/2012 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 19.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | ||
| 164 | NCT01849783 (ClinicalTrials.gov) | April 4, 2013 | 6/5/2013 | Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma | Single Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell Malignancy | Extramedullary Plasmacytoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Primary Systemic Amyloidosis;Stage I Multiple Myeloma;Stage II Multiple Myeloma;Stage III Multiple Myeloma | Drug: dexamethasone;Drug: cisplatin;Drug: doxorubicin;Drug: cyclophosphamide;Drug: etoposide;Drug: bortezomib;Drug: thalidomide;Drug: melphalan;Procedure: autologous stem cell transplant | Yogesh Jethava | National Cancer Institute (NCI) | Active, not recruiting | 65 Years | 85 Years | All | 41 | Phase 2 | United States |
| 165 | NCT02015312 (ClinicalTrials.gov) | April 2013 | 18/11/2013 | A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL) | A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL) | Light Chain (AL) Amyloidosis;Cardiac Involvement | Drug: Epigallocatechin-3-gallate (EGCG);Drug: Placebo | Florian Michel | German Federal Ministry of Education and Research | Completed | 18 Years | N/A | All | 38 | Phase 2 | Germany |
| 166 | NCT01737398 (ClinicalTrials.gov) | March 15, 2013 | 27/11/2012 | Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study) | FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;Amyloidosis | Drug: Inotersen;Drug: Placebo | Ionis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 82 Years | All | 173 | Phase 2/Phase 3 | United States;Argentina;Brazil;France;Germany;Italy;New Zealand;Portugal;Spain;United Kingdom;Bulgaria |
| 167 | NCT01728259 (ClinicalTrials.gov) | March 2013 | 13/11/2012 | First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDD | Phase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition Disease | Light Chain Deposition Disease;Primary Systemic Amyloidosis | Drug: pomalidomide;Drug: bortezomib;Drug: dexamethasone;Other: Laboratory Biomarker Analysis | Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) | Active, not recruiting | 18 Years | N/A | All | 36 | Phase 1 | United States;Canada;New Zealand |
| 168 | EUCTR2012-001831-30-PT (EUCTR) | 21/02/2013 | 20/11/2012 | A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid Polyneuropathy | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 | Familial Amyloid Polyneuropathy MedDRA version: 19.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | France;United States;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom | ||
| 169 | NCT01222260 (ClinicalTrials.gov) | January 2013 | 14/10/2010 | Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis | Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis | AL Amyloidosis | Drug: Bendamustine;Drug: Dexamethasone | Columbia University | Cephalon | Completed | 18 Years | N/A | All | 40 | Phase 2 | United States |
| 170 | EUCTR2010-022395-31-DE (EUCTR) | 25/10/2012 | 18/10/2012 | Clinical trial of Melphalan and Dexamethasone versus Bortezomib, Melphalan and Dexamethasone for untreated patients with systemic light-chain (AL) amyloidosis | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - AC-004-EU | AL amyloidosis MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Velcade INN or Proposed INN: BORTEZOMIB Trade Name: Fortecortin Product Name: Dexamethason INN or Proposed INN: Dexamethasone Other descriptive name: DEXAMETHASONE Trade Name: Alkeran Product Name: Melphalan INN or Proposed INN: MELPHALAN | European Myeloma Network | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;Czech Republic;Greece;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 171 | JPRN-UMIN000008396 | 2012/08/01 | 10/07/2012 | A randomized, double-blind, placebo-controlled trial of diflunisal on familial amyloid polyneuropathy | patients of familial amyloid polyneuropathy | Diflunisal, 500mg / day, PO, 1 year Parse, 500mg / day, PO, 1 year | Department of Neurology, Faculty of Life Sciences, Kumamoto University | NULL | Complete: follow-up complete | 18years-old | 65years-old | Male and Female | 1 | Phase 3 | Japan | |
| 172 | EUCTR2010-022395-31-ES (EUCTR) | 13/06/2012 | 21/05/2012 | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | AL Amyloidosis MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VELCADE INN or Proposed INN: BORTEZOMIB Other descriptive name: VELCADE Trade Name: Dexamethasone Product Name: Dexamethasone Product Code: Dexametasone Other descriptive name: DEXAMETHASONE Trade Name: melphalan Product Name: Melphalan Product Code: melphalan INN or Proposed INN: MELPHALAN Trade Name: betamethasone Product Name: Dexamethasone INN or Proposed INN: oral drops solution Other descriptive name: DEXAMETHASONE Trade Name: melphalan Product Name: Melphalan INN or Proposed INN: MELPHALAN | E.M.N. - EUROPEAN MYELOMA NETWORK | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United Kingdom;Germany;Netherlands;Denmark;Norway;France;Spain;Italy;Greece;Sweden | ||
| 173 | NCT01570387 (ClinicalTrials.gov) | June 2012 | 27/2/2012 | A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis | A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis | AL Amyloidosis | Drug: Pomalidomide;Drug: Dexamethasone | Boston Medical Center | Celgene Corporation | Completed | 18 Years | N/A | All | 27 | Phase 1/Phase 2 | United States |
| 174 | EUCTR2010-021445-42-BE (EUCTR) | 10/05/2012 | 10/10/2011 | A study in which is investigated if the medicine bortezomib is effective in patietns with AL amylodosis. | A multicenter, randomized phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis | AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Velcade INN or Proposed INN: BORTEZOMIB | HOVON Foundation | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Belgium;Germany;Netherlands | ||
| 175 | EUCTR2010-021445-42-DE (EUCTR) | 09/05/2012 | 23/01/2012 | A study to investigated whether bortezomib is effective in patients with AL amyloidosis | A multicenter, prospective study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL Amyloidosis | AL Amyloidosis MedDRA version: 17.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Velcade INN or Proposed INN: BORTEZOMIB Trade Name: Fortecortin Product Name: Fortecortin INN or Proposed INN: Dexamethasone Trade Name: Fortecortin Product Name: Fortecortin INN or Proposed INN: Dexamethasone | HOVON Foundation | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Belgium;Netherlands;Germany | ||
| 176 | EUCTR2010-022395-31-GR (EUCTR) | 02/05/2012 | 02/04/2012 | N/A | N/A - BMDex vs MDex for AL amyloidosis | Primary Systemic (AL) Amyloidosis MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: VELCADE INN or Proposed INN: BORTEZOMIB Trade Name: Dexaton INN or Proposed INN: Dexamethasone Other descriptive name: DEXAMETHASONE Trade Name: Alkeran INN or Proposed INN: MELPHALAN Trade Name: Dexaton INN or Proposed INN: Dexamethasone Other descriptive name: DEXAMETHASONE Trade Name: Alkeran INN or Proposed INN: MELPHALAN | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | United Kingdom;Denmark;Spain;Italy;Greece;Sweden;Australia | |||
| 177 | EUCTR2011-001787-22-IT (EUCTR) | 02/05/2012 | 12/01/2012 | Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis. | An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex | Previously treated AL amyloidosis MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: pomalidomide Product Code: CC-4047 INN or Proposed INN: Pomalidomide INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE | OSPEDALE POLICLINICO S. MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy | |||
| 178 | NCT01510613 (ClinicalTrials.gov) | February 2012 | 11/1/2012 | Pomalidomide and Dexamethasone (PDex) in AL Amyloidosis | An Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis. | Primary Amyloidosis of Light Chain Type | Drug: Pomalidomide and Dexamethasone | IRCCS Policlinico S. Matteo | NULL | Completed | 18 Years | N/A | All | 28 | Phase 2 | Italy |
| 179 | NCT01511263 (ClinicalTrials.gov) | January 2012 | 10/1/2012 | Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis | A Phase II Open-label Randomized Study of Dietary Supplement With Epigallocatechin Gallate (EGCG) to Improve Cardiac Dysfunction in Patients With AL Amyloidosis Who do Not Require Chemotherapy (EpiCardiAL) | Primary Amyloidosis of Light Chain Type | Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias);Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG | IRCCS Policlinico S. Matteo | NULL | Terminated | 18 Years | N/A | All | 86 | Phase 2 | Italy |
| 180 | EUCTR2010-022395-31-DK (EUCTR) | 14/11/2011 | 09/06/2011 | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | AL Amyloidosis MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: VELCADE Product Name: bortezomib Product Name: Dexamethasone Trade Name: Alkeran Product Name: Melphalan Product Name: Dexamethasone Product Name: Melphalan | E.M.N. - EUROPEAN MYELOMA NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Czech Republic;Greece;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 181 | JPRN-JapicCTI-111678 | 07/11/2011 | 02/11/2011 | The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin | The Effect Of Transthyretin Stabilization, Safety, Tolerability, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin: A Phase 3, Open-Label(B3461010) | Transthyretin Familial Amyloid Polyneuropathy | Intervention name : tafamidis meglumine INN of the intervention : tafamidis meglumine Dosage And administration of the intervention : 20 mg QD Control intervention name : null | Pfizer Japan Inc. | NULL | 20 | 75 | BOTH | 10 | Phase 3 | NULL | |
| 182 | JPRN-UMIN000006604 | 2011/11/01 | 24/10/2011 | Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis. | To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis. | Patients receive oral melphalan 8 mg/m2 on days 1-4, bortezomib SC (IV) on days 1, 4, 8 and 11, and dexamethasone orally on days 1-2, 4-5 8-9 11 and 12. Treatment repeats every 4 weeks (28 days) for up to 4 cycles in the absence of disease progression or unacceptable toxicity. *The preventive medication on last medication day after the 28th is recommended in principle from acyclovir 200 or 400 mg/the bortezomib medication opening day of a day. Moreover, when the symptoms of herpes are shown, the acyclovir or the rose cyclo building of a therapeutic amount is promptly prescribed for the patient. | Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology | NULL | Complete: follow-up complete | 20years-old | 65years-old | Male and Female | 21 | Phase 1,2 | Japan | |
| 183 | NCT01435655 (ClinicalTrials.gov) | November 2011 | 13/9/2011 | The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin | The Effect On Transthyretin Stabilization, Safety, Tolerablity, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30m Or Non-v30m Transthyretin: A Phase Iii, Open-label Study | Transthyretin Familial Amyloid Polyneuropathy | Drug: tafamidis | Pfizer | NULL | Completed | 20 Years | 75 Years | All | 10 | Phase 3 | Japan |
| 184 | NCT01406314 (ClinicalTrials.gov) | October 13, 2011 | 26/7/2011 | SAP Depleter Dose Assessment Study in Patients | A Phase 1, Open Label, Dose Characteristic Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Intravenous and Subcutaneous Doses of GSK2315698A in Patients With Systemic Amyloidosis | Amyloidosis | Drug: GSK2315698 | GlaxoSmithKline | NULL | Completed | 18 Years | 80 Years | All | 17 | Phase 1 | United Kingdom |
| 185 | EUCTR2010-021445-42-NL (EUCTR) | 31/08/2011 | 27/01/2011 | A study in which is investigated if the medicine bortezomib is effective in patients with AL amyloidosis | A multicenter, phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis | AL Amyloidosis MedDRA version: 16.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Velcade INN or Proposed INN: BORTEZOMIB | HOVON Foundation | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Belgium;Germany;Netherlands | ||
| 186 | NCT01383759 (ClinicalTrials.gov) | June 24, 2011 | 27/6/2011 | Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis | Pilot Study of Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis | Light Chain Deposition Disease (LCDD or MIDD);Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD);Monoclonal Immunoglobulin Deposition Disease (MIDD);Amyloidosis | Drug: Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone | Memorial Sloan Kettering Cancer Center | Millennium Pharmaceuticals, Inc. | Completed | 18 Years | N/A | All | 20 | N/A | United States |
| 187 | EUCTR2010-022395-31-SE (EUCTR) | 10/06/2011 | 12/04/2011 | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | AL Amyloidosis MedDRA version: 13.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: VELCADE Product Name: Dexamethasone Product Name: Melphalan Product Name: Dexamethasone Product Name: Melphalan | E.M.N. - EUROPEAN MYELOMA NETWORK | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United Kingdom;Denmark;Spain;Italy;Greece;Sweden | ||
| 188 | NCT01273844 (ClinicalTrials.gov) | March 1, 2011 | 3/1/2011 | Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL) | Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL | Amyloidosis | Drug: Bortezomib | Zhi-Hong Liu, M.D. | Soochow University;Nanjing Medical University | Completed | 18 Years | 65 Years | All | 21 | N/A | China |
| 189 | NCT01277016 (ClinicalTrials.gov) | January 2011 | 10/1/2011 | A Trial for Systemic Light-chain (AL) Amyloidosis | A Randomized Open-label Multicenter Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-chain (AL) Amyloidosis | AL Amyloidosis | Drug: BMDex | European Myeloma Network | NULL | Completed | 18 Years | N/A | All | 110 | Phase 3 | Italy |
| 190 | NCT01199562 (ClinicalTrials.gov) | December 2010 | 8/9/2010 | Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant | Modified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune Function | Hematopoietic/Lymphoid Cancer;Accelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Atypical Chronic Myeloid Leukemia, BCR-ABL Negative;Blastic Phase Chronic Myelogenous Leukemia;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Contiguous Stage II Adult Burkitt Lymphoma;Contiguous Stage II Adult Diffuse Large Cell Lymphoma;Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Contiguous Stage II Adult Lymphoblastic Lymphoma;Contiguous Stage II Grade 1 Follicular Lymphoma;Contiguous Stage II Grade 2 Follicular Lymphoma;Contiguous Stage II Grade 3 Follicular Lymphoma;Contiguous Stage II Mantle Cell Lymphoma;Contiguous Stage II Marginal Zone Lymphoma;Contiguous Stage II Small Lymphocytic Lymphoma;Cutaneous B-cell Non-Hodgkin Lymphoma;Cytomegalovirus Infection;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Mast Cell Leukemia;Meningeal Chronic Myelogenous Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Splenic Marginal Zone Lymphoma;Stage 0 Chronic Lymphocytic Leukemia;Stage I Adult Burkitt Lymphoma;Stage I Adult Diffuse Large Cell Lymphoma;Stage I Adult Diffuse Mixed Cell Lymphoma;Stage I Adult Diffuse Small Cleaved Cell Lymphoma;Stage I Adult Hodgkin Lymphoma;Stage I Adult Immunoblastic Large Cell Lymphoma;Stage I Adult Lymphoblastic Lymphoma;Stage I Adult T-cell Leukemia/Lymphoma;Stage I Chronic Lymphocytic Leukemia;Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;Stage I Grade 1 Follicular Lymphoma;Stage I Grade 2 Follicular Lymphoma;Stage I Grade 3 Follicular Lymphoma;Stage I Mantle Cell Lymphoma;Stage I Marginal Zone Lymphoma;Stage I Multiple Myeloma;Stage I Mycosis Fungoides/Sezary Syndrome;Stage I Small Lymphocytic Lymphoma;Stage II Adult Hodgkin Lymphoma;Stage II Adult T-cell Leukemia/Lymphoma;Stage II Chronic Lymphocytic Leukemia;Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;Stage II Multiple Myeloma;Stage II Mycosis Fungoides/Sezary Syndrome;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Hodgkin Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Adult T-cell Leukemia/Lymphoma;Stage III Chronic Lymphocytic Leukemia;Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Mycosis Fungoides/Sezary Syndrome;Stage III Small Lymphocytic Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Mycosis Fungoides/Sezary Syndrome;Stage IV Small Lymphocytic Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia | Procedure: infection prophylaxis and management;Other: laboratory biomarker analysis;Other: flow cytometry;Genetic: DNA analysis;Genetic: RNA analysis;Procedure: management of therapy complications;Drug: ganciclovir;Drug: valganciclovir;Drug: foscarnet sodium;Procedure: antiviral therapy;Genetic: polymerase chain reaction;Genetic: protein expression analysis | City of Hope Medical Center | National Cancer Institute (NCI) | Completed | 18 Years | N/A | All | 153 | United States | |
| 191 | NCT01078454 (ClinicalTrials.gov) | November 2010 | 27/2/2010 | Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis | A Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-Chain (AL) Amyloidosis Ineligible for Autologous Stem-Cell Transplantation | Light Chain Deposition Disease;Primary Systemic Amyloidosis | Drug: melphalan;Drug: dexamethasone;Drug: bortezomib | National Cancer Institute (NCI) | NULL | Completed | 18 Years | N/A | All | 11 | Phase 3 | United States |
| 192 | EUCTR2010-022395-31-IT (EUCTR) | 07/10/2010 | 01/12/2010 | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - ND | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - ND | AL amyloidosis MedDRA version: 9.1;Level: HLGT;Classification code 10035227 | Trade Name: VELCADE INN or Proposed INN: Bortezomib INN or Proposed INN: Melphalan INN or Proposed INN: Dexamethasone INN or Proposed INN: Melphalan INN or Proposed INN: Dexamethasone | E.M.N. - EUROPEAN MYELOMA NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 193 | NCT01194791 (ClinicalTrials.gov) | October 2010 | 26/7/2010 | Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed | A Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell Transplantation | Primary Systemic Amyloidosis | Drug: Lenalidomide;Drug: Cyclophosphamide;Drug: Dexamethasone | PETHEMA Foundation | NULL | Completed | 18 Years | N/A | All | 30 | Phase 2 | Spain |
| 194 | EUCTR2009-014906-33-GB (EUCTR) | 17/09/2010 | 18/06/2010 | A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEAL | A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEAL | Systemic AL amyloidosis MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Velcade Product Name: bortezomib INN or Proposed INN: bortezomib Trade Name: Velcade Product Name: bortezomib INN or Proposed INN: bortezomib | University College London | NULL | Not Recruiting | Female: yes Male: yes | 52 | United Kingdom | |||
| 195 | EUCTR2006-001066-16-GB (EUCTR) | 25/08/2010 | 18/06/2010 | A randomized, double-blind, placebo-controlled, international multi-center trial ofdiflunisal on neurologic disease progression in 200 familial amyloid subjects - The effect of diflunisal on familial amyloidosis | A randomized, double-blind, placebo-controlled, international multi-center trial ofdiflunisal on neurologic disease progression in 200 familial amyloid subjects - The effect of diflunisal on familial amyloidosis | Hereditary neuropathic amyloidosis MedDRA version: 11.;Level: LLT;Classification code 10019889;Term: Hereditary neuropathic amyloidosis | Trade Name: Dolobid Product Name: diflunisal (dolobid) INN or Proposed INN: diflunisal Other descriptive name: 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid | John L. Berk | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | United Kingdom;Italy;Sweden | |||
| 196 | NCT01072773 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis | Phase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain Amyloidosis | Primary Systemic Amyloidosis | Drug: bortezomib;Drug: cyclophosphamide;Drug: dexamethasone | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 2 | Phase 2 | United States |
| 197 | EUCTR2009-011535-12-IT (EUCTR) | 14/01/2010 | 25/11/2009 | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - ND | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - ND | Patients with Transthyretin Amyloidosis MedDRA version: 12.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Name: Fx-1006A Product Code: Fx-1006A | FOLDRX PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Portugal;Germany;France;Italy;Sweden | |||
| 198 | EUCTR2009-011535-12-PT (EUCTR) | 09/09/2009 | 15/07/2009 | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis | Transthyretin Amyloidosis (ATTR) MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Tafamidis meglumine Product Code: Fx-1006A INN or Proposed INN: tafamidis Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-,2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)] | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | France;United States;Portugal;Argentina;Brazil;Germany;Italy;Sweden | |||
| 199 | NCT01083316 (ClinicalTrials.gov) | September 2009 | 2/11/2009 | Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis | Phase II Trial of Induction Therapy With Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation in Patients With AL Amyloidosis | Amyloidosis | Drug: Bortezomib;Drug: Dexamethasone;Drug: Melphalan | Boston Medical Center | Millennium Pharmaceuticals, Inc. | Completed | 18 Years | N/A | All | 35 | Phase 2 | United States |
| 200 | EUCTR2009-011535-12-DE (EUCTR) | 26/08/2009 | 18/05/2009 | In preparation | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis | Transthyretin Amyloidosis (ATTR) MedDRA version: 14.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Tafamidis meglumine Product Code: Fx-1006A INN or Proposed INN: tafamidis Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)] | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Portugal;Germany;Argentina;France;Italy;United States;Sweden;Brazil | |||
| 201 | NCT00890747 (ClinicalTrials.gov) | August 2009 | 29/4/2009 | Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral Therapy | A Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART Therapy | Accelerated Phase Chronic Myelogenous Leukemia;Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Langerhans Cell Histiocytosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aggressive NK-cell Leukemia;AIDS-related Diffuse Large Cell Lymphoma;AIDS-related Diffuse Mixed Cell Lymphoma;AIDS-related Diffuse Small Cleaved Cell Lymphoma;AIDS-related Immunoblastic Large Cell Lymphoma;AIDS-related Lymphoblastic Lymphoma;AIDS-related Malignancies;AIDS-related Small Noncleaved Cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Clear Cell Renal Cell Carcinoma;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;HIV Infection;HIV-associated Hodgkin Lymphoma;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Mast Cell Leukemia;Myelodysplastic Syndrome With Isolated Del(5q);Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Osteolytic Lesions of Multiple Myeloma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Renal Cell Cancer;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Stage IV Renal Cell Cancer;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Waldenström Macroglobulinemia | Drug: sunitinib malate;Other: pharmacological study;Other: laboratory biomarker analysis | National Cancer Institute (NCI) | NULL | Completed | 18 Years | N/A | Both | 42 | Phase 1 | United States |
| 202 | EUCTR2009-011535-12-FR (EUCTR) | 31/07/2009 | 19/06/2009 | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis | Transthyretin Amyloidosis (ATTR) MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Name: Fx-1006A Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylat | FoldRx Pharmaceuticals, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Portugal;Germany;France;Italy;Sweden | |||
| 203 | EUCTR2009-011535-12-SE (EUCTR) | 24/06/2009 | 10/06/2009 | To obtain additional long-term, safety and efficacy data for tafamidis in subjects with transthyretin (TTR) familial amyloid polyneuropathy (TTR-FAP) and to continue to provide the Tafamidis to subjects with TTR-FAP who have completed Protocol Fx-006 or Protocol Fx1A-201 | Open-Label Safety and Efficacy Evaluation of Fx-1006A in Subjects with Transthyretin (TTR) Amyloidosis | Transthyretin Amyloidosis (ATTR) MedDRA version: 16.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Vyndaqel 20mg soft capsule Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Clinical trial image) Product Code: PF-06291826-83/Fx-1006A INN or Proposed INN: Tafamidis meglumine Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules Trade Name: Vyndaqel 20mg soft capsule Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Commerical image) Product Code: PF-06291826-83/Fx-1006A INN or Proposed INN: Tafamidis meglumine Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden | |||
| 204 | JPRN-UMIN000001825 | 2009/04/01 | 31/03/2009 | Treatment of familial amyloid polyneuropathy (FAP) using diflunisal | familial amyloid polyneuropathy (FAP) | Orally administration of diflunisal | Shinshu University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| 205 | NCT00890552 (ClinicalTrials.gov) | April 2009 | 28/4/2009 | A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis | A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis | Leukemia;Amyloidosis | Drug: Lenalidomide;Drug: Melphalan;Drug: Dexamethasone | Stanford University | Celgene Corporation | Completed | 18 Years | N/A | All | 25 | N/A | United States |
| 206 | NCT00883623 (ClinicalTrials.gov) | April 2009 | 15/4/2009 | A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis | A Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL Amyloidosis | Primary Amyloidosis | Drug: Lenalidomide | Heidelberg University | Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH | Completed | 18 Years | 74 Years | Both | 50 | Phase 2 | Germany |
| 207 | EUCTR2008-001262-87-DE (EUCTR) | 16/03/2009 | 29/01/2009 | An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable | Transthyretin Amyloid Polyneuropathy (ATTR-PN) MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Name: Fx-1006A Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate | FoldRx Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 107 | Portugal;Germany;France;Sweden | ||||
| 208 | NCT01815086 (ClinicalTrials.gov) | December 2008 | 13/3/2013 | Radioimmunoimaging of Light Chain (AL) Amyloidosis | Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4 | AL Amyloidosis | Biological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) | University of Tennessee | NULL | Completed | 21 Years | 90 Years | Both | 30 | Phase 1 | United States |
| 209 | NCT00807872 (ClinicalTrials.gov) | December 2008 | 11/12/2008 | Radioimmunoimaging of AL Amyloidosis | Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4 | Primary Amyloidosis | Biological: 124I-labeled monoclonal antibody Mu 11-1F4 | University of Tennessee | FDA Office of Orphan Products Development | Completed | 21 Years | 90 Years | Both | 40 | Phase 1 | United States |
| 210 | NCT01409148 (ClinicalTrials.gov) | November 2008 | 28/7/2011 | Radioimmunoimaging of AL Amyloidosis | Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4 | AL Amyloidosis | Biological: 124I-labeled monoclonal antibody Mu 11-1F4 | University of Tennessee | Food and Drug Administration (FDA) | Completed | 21 Years | 90 Years | Both | 38 | Phase 1 | United States |
| 211 | EUCTR2008-001405-41-DE (EUCTR) | 24/10/2008 | 28/08/2008 | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | AL amyloidosis | Trade Name: Revlimid Other descriptive name: Lenalidomide Trade Name: Alkeran Product Code: L01AA03 Other descriptive name: melphalan Trade Name: Fortecortin Other descriptive name: dexamethasone | GMIHO mbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 212 | EUCTR2007-006791-12-IT (EUCTR) | 15/09/2008 | 24/07/2008 | The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis - ND | The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis - ND | Patients with Non-V30M Transthyretin Amyloidosis MedDRA version: 9.1;Level: LLT;Classification code 10016202;Term: Familial amyloidosis | Product Code: Fx-1006A | FOLDRX PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 16 | Germany;France;Italy | |||
| 213 | EUCTR2008-001262-87-FR (EUCTR) | 04/07/2008 | 30/05/2008 | An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable | An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable | Transthyretin Amyloid Polyneuropathy (ATTR-PN) MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Name: Fx-1006A Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate | FoldRx Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 107 | Phase 2;Phase 3 | Portugal;France;Germany;Sweden | ||
| 214 | EUCTR2008-001262-87-PT (EUCTR) | 04/07/2008 | 21/04/2008 | An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable | Transthyretin Amyloid Polyneuropathy (ATTR-PN) MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Name: Fx-1006A Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate | FoldRx Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 107 | Portugal;Germany;France;Sweden | ||||
| 215 | NCT00791492 (ClinicalTrials.gov) | July 2008 | 13/11/2008 | An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy | An Open-Label Extension Of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy | Familial Amyloid Polyneuropathy;ATTR-PN | Drug: Fx-1006A | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 86 | Phase 2/Phase 3 | Argentina;Brazil;France;Germany;Portugal;Sweden |
| 216 | EUCTR2008-001262-87-SE (EUCTR) | 23/06/2008 | 26/05/2008 | An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable | Transthyretin Amyloid Polyneuropathy (ATTR-PN) MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Name: Fx-1006A Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate | FoldRx Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 107 | Portugal;Germany;France;Sweden | ||||
| 217 | NCT00790647 (ClinicalTrials.gov) | June 2008 | 12/11/2008 | Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis | Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis | Multiple Myeloma | Biological: filgrastim;Drug: bortezomib;Drug: melphalan;Procedure: Stem Cell Infusion | Boston Medical Center | NULL | Completed | 18 Years | 65 Years | All | 10 | Phase 2 | United States |
| 218 | NCT00679367 (ClinicalTrials.gov) | May 2008 | 14/5/2008 | Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis | A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis | Multiple Myeloma | Drug: dexamethasone;Drug: lenalidomide;Drug: melphalan | Boston Medical Center | NULL | Completed | 18 Years | N/A | All | 16 | Phase 2 | United States |
| 219 | EUCTR2007-006037-13-IT (EUCTR) | 21/02/2008 | 10/12/2007 | An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND | An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND | amyloidosis AL MedDRA version: 6.1;Level: PT;Classification code 10002022 | Trade Name: Revlimid INN or Proposed INN: Cyclophosphamide INN or Proposed INN: Dexamethasone | OSPEDALE POLICLINICO S. MATTEO | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | |||
| 220 | NCT00607581 (ClinicalTrials.gov) | February 2008 | 22/1/2008 | Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis | An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis | Amyloidosis | Drug: cyclophosphamide;Drug: lenalidomide;Drug: dexamethasone | IRCCS Policlinico S. Matteo | Celgene Corporation | Completed | 18 Years | N/A | Both | 21 | Phase 2 | Italy |
| 221 | NCT00981708 (ClinicalTrials.gov) | February 2008 | 19/9/2009 | Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL) | A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis | Amyloidosis | Drug: Lenalidomide, Dexamethasone and Cyclophosphamide | University of Athens | Hellenic Cooperative Oncology Group | Completed | 18 Years | N/A | All | 37 | Phase 1/Phase 2 | Greece |
| 222 | NCT00564889 (ClinicalTrials.gov) | December 2007 | 28/11/2007 | Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis | A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Drug: cyclophosphamide;Drug: dexamethasone;Drug: lenalidomide | Mayo Clinic | National Cancer Institute (NCI) | Completed | 18 Years | N/A | All | 35 | Phase 2 | United States |
| 223 | NCT01998503 (ClinicalTrials.gov) | December 2007 | 15/11/2013 | Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis | Induction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL Amyloidosis | Amyloidosis | Drug: Bortezomib;Drug: dexamethasone;Biological: filgrastim;Procedure: autologous hematopoietic stem cell transplantation (ASCT);Drug: Melphalan | Nanjing University School of Medicine | NULL | Completed | 18 Years | 65 Years | Both | 56 | Phase 3 | China |
| 224 | EUCTR2006-007082-36-GR (EUCTR) | 16/10/2007 | 18/07/2007 | A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis | A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis | Primary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatments | Trade Name: REVLIMID Trade Name: Endoxan Trade Name: Dexamethasone Trade Name: REVLIMID INN or Proposed INN: Lenalidomide INN or Proposed INN: Deaxamethasone INN or Proposed INN: cyclophosphamide | Hellenic Oncology Cooperative Group | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 1/2 | Greece | ||
| 225 | EUCTR2006-002792-41-DE (EUCTR) | 08/10/2007 | 20/06/2007 | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): A Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study - Not applicable | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): A Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study - Not applicable | Familial Amyloid Polyneuropathy (FAP) MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate | FoldRx Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2/3 | Portugal;United Kingdom;Germany;Spain;Sweden | ||
| 226 | EUCTR2006-006395-37-GB (EUCTR) | 06/09/2007 | 31/07/2007 | A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) | A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) | The medical condition to be investigated is systemic AL Amyloidosis, a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function. MedDRA version: 9.1;Level: LLT;Classification code 10002022;Term: Amyloidosis | Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Product Name: Dexamethasone INN or Proposed INN: DEXAMETHASONE Product Name: Dexamethasone INN or Proposed INN: DEXAMETHASONE Trade Name: Lenogastrim Other descriptive name: GRANULOCYTE COLONY STIMULATING FACTOR Product Name: Melphalan INN or Proposed INN: MELPHALAN | Joint UCLH and UCL Biomedical Research Unit | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 227 | NCT00520767 (ClinicalTrials.gov) | September 2007 | 24/8/2007 | Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease | A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease | Primary Systemic Amyloidosis;Light Chain Deposition Disease | Drug: bortezomib;Drug: dexamethasone;Drug: melphalan;Genetic: microarray analysis;Other: flow cytometry;Other: laboratory biomarker analysis;Procedure: quality-of-life assessment | Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) | Active, not recruiting | 18 Years | 120 Years | All | 35 | Phase 2 | United States |
| 228 | EUCTR2006-002792-41-GB (EUCTR) | 06/07/2007 | 29/09/2006 | Safety and efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Safety and efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Familial Amyloid Polyneuropathy (FAP). | Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylat | FoldRx Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2;Phase 3 | Portugal;Spain;Germany;United Kingdom;Sweden | ||
| 229 | NCT00458822 (ClinicalTrials.gov) | February 2007 | 9/4/2007 | Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis | Risk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Drug: bortezomib;Drug: dexamethasone | Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) | Completed | 18 Years | 70 Years | All | 40 | Phase 2 | United States |
| 230 | EUCTR2006-001066-16-IT (EUCTR) | 30/01/2007 | 09/03/2007 | The effect of diflunisal IND 68092 on familial amyloidosis a randomized, double-blind, placebo-controlled, international multi-center trial of diflunisal on neurologic disease progression in 200 familial amyloid subjects. - ND | The effect of diflunisal IND 68092 on familial amyloidosis a randomized, double-blind, placebo-controlled, international multi-center trial of diflunisal on neurologic disease progression in 200 familial amyloid subjects. - ND | familial amyloidosis MedDRA version: 9.1;Level: LLT;Classification code 10016202;Term: Familial amyloidosis | Trade Name: Dolobid | Boston University- The Amyloid Treatment and Research Program | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | United Kingdom;Italy;Sweden | |||
| 231 | EUCTR2006-001066-16-SE (EUCTR) | 04/01/2007 | 09/11/2006 | The effect of diflunisal (IND 68092) on familial amyloidosis - The Diflunisal Trial | The effect of diflunisal (IND 68092) on familial amyloidosis - The Diflunisal Trial | Familial Amyloid Polyneuropathy (FAP) | Trade Name: Dolobid Product Name: diflunisal (dolobid) INN or Proposed INN: diflunisal Other descriptive name: 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid | John L. Berk, M.D. | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Italy;Sweden | |||
| 232 | NCT00409175 (ClinicalTrials.gov) | January 2007 | 6/12/2006 | Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis | Safety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled Study | Familial Amyloid Polyneuropathy | Drug: Fx-1006A;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 128 | Phase 2/Phase 3 | United States;Argentina;Brazil;France;Germany;Portugal;Spain;Sweden;United Kingdom |
| 233 | EUCTR2006-002792-41-PT (EUCTR) | 23/11/2006 | 14/09/2006 | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Familial Amyloid Polyneuropathy (FAP). | Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate | FoldRx Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2/3 | Portugal;Germany;United Kingdom;Spain;Sweden | ||
| 234 | EUCTR2006-002792-41-SE (EUCTR) | 30/10/2006 | 01/09/2006 | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study | Familial Amyloid Polyneuropathy (FAP). MedDRA version: 9.1;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy | Product Code: Fx-1006A Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate | FoldRx Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2/3 | Portugal;Germany;United Kingdom;Spain;Sweden | ||
| 235 | EUCTR2006-001927-20-IT (EUCTR) | 01/07/2006 | 15/06/2007 | Treatment with Anakinra in TRAPS - ND | Treatment with Anakinra in TRAPS - ND | TRAPS MedDRA version: 9.1;Level: LLT;Classification code 10016202;Term: Familial amyloidosis | Trade Name: KINERET*SC 7SIR 100MG 0,67ML INN or Proposed INN: Anakinra | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 236 | NCT00536601 (ClinicalTrials.gov) | June 29, 2006 | 27/9/2007 | High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors | Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors | Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET);Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Nodal Marginal Zone B-cell Lymphoma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Malignant Testicular Germ Cell Tumor;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Neuroblastoma;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Regional Neuroblastoma;Splenic Marginal Zone Lymphoma;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström Macroglobulinemia | Drug: etoposide;Drug: cyclophosphamide;Drug: carmustine;Drug: melphalan;Drug: busulfan;Drug: carboplatin;Drug: thiotepa;Radiation: total-body irradiation;Procedure: autologous hematopoietic stem cell transplantation;Procedure: autologous-autologous tandem hematopoietic stem cell transplantation | Roswell Park Cancer Institute | National Cancer Institute (NCI) | Completed | 4 Years | N/A | All | 174 | N/A | United States |
| 237 | NCT00294671 (ClinicalTrials.gov) | February 2006 | 21/2/2006 | The Effect of Diflunisal on Familial Amyloidosis | The Effect of Diflunisal on Familial Amyloidosis | Familial Amyloid Polyneuropathy;Familial Amyloidosis | Drug: diflunisal;Other: placebo | Boston University | Food and Drug Administration (FDA);National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 75 Years | All | 130 | Phase 2/Phase 3 | United States;Italy;Japan;Sweden;United Kingdom;Portugal |
| 238 | NCT00477971 (ClinicalTrials.gov) | October 2005 | 23/5/2007 | Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis | Phase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL) | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: dexamethasone;Drug: melphalan;Procedure: autologous hematopoietic stem cell transplantation | Mayo Clinic | National Cancer Institute (NCI) | Completed | 18 Years | N/A | All | 89 | Phase 3 | United States |
| 239 | EUCTR2004-004871-12-IT (EUCTR) | 02/05/2005 | 07/06/2005 | An Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-Amyloidosis | An Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-Amyloidosis | Systemic AL-Amyloidosis MedDRA version: 6.1;Level: PT;Classification code 10002022 | Trade Name: VELCADE*1FL 3,5MG Product Name: NA Product Code: NA INN or Proposed INN: Bortezomib | JANSSEN-CILAG | NULL | Not Recruiting | Female: yes Male: yes | Phase 1/2 | Italy | |||
| 240 | NCT00166413 (ClinicalTrials.gov) | April 2005 | 12/9/2005 | Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic Amyloidosis | A Phase II Trial of CC-5013 in Patients With Primary Systemic Amyloidosis | Amyloidosis | Drug: CC-5013 | Mayo Clinic | NULL | Completed | 18 Years | N/A | Both | 38 | Phase 2 | United States |
| 241 | NCT00064337 (ClinicalTrials.gov) | January 2004 | 8/7/2003 | S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis | S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study) | Multiple Myeloma;Plasma Cell Myeloma | Biological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantation | Southwest Oncology Group | National Cancer Institute (NCI) | Completed | 18 Years | 120 Years | All | 104 | Phase 2 | United States |
| 242 | NCT00091260 (ClinicalTrials.gov) | January 2004 | 7/9/2004 | CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis | A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis | Multiple Myeloma | Drug: dexamethasone;Drug: lenalidomide | Vaishali Sanchorawala | Celgene Corporation | Completed | 18 Years | N/A | All | 82 | Phase 2 | United States |
| 243 | NCT00052884 (ClinicalTrials.gov) | October 2003 | 24/1/2003 | Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation | A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis | Drug/Agent Toxicity by Tissue/Organ;Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: amifostine trihydrate;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantation | Eastern Cooperative Oncology Group | National Cancer Institute (NCI) | Terminated | 18 Years | 70 Years | Both | 8 | Phase 1 | United States |
| 244 | NCT01527032 (ClinicalTrials.gov) | September 2002 | 28/7/2011 | Risk-adapted Therapy for Primary Systemic (AL) Amyloidosis | Risk-adapted Therapy for AL Amyloidosis | Amyloidosis | Drug: melphalan, thalidomide and dexamethasone | FDA Office of Orphan Products Development | NULL | Completed | Phase 2 | NULL | ||||
| 245 | NCT00089167 (ClinicalTrials.gov) | May 2002 | 4/8/2004 | Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis | Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide | Memorial Sloan Kettering Cancer Center. | National Cancer Institute (NCI) | Completed | 18 Years | N/A | Both | Phase 2 | United States | |
| 246 | NCT00030381 (ClinicalTrials.gov) | December 2001 | 14/2/2002 | Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis | Phase I Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL) | Primary Systemic Amyloidosis | Drug: 4'-iodo-4'-deoxydoxorubicin;Other: pharmacological study | National Cancer Institute (NCI) | NULL | Terminated | 18 Years | N/A | Both | 22 | Phase 1 | United States |
| 247 | NCT00075608 (ClinicalTrials.gov) | August 2001 | 9/1/2004 | 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis | Phase II Trial of Second Autologous Transplantation in AL Amyloidosis | Multiple Myeloma;Plasma Cell Neoplasm | Biological: filgrastim;Drug: melphalan;Procedure: autologous stem cell transplantation;Procedure: stem cell infusion | Boston Medical Center | NULL | Terminated | 18 Years | 65 Years | All | 12 | Phase 2 | United States |
| 248 | NCT00025415 (ClinicalTrials.gov) | August 2001 | 11/10/2001 | Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction | A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction | Accelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;AIDS-related Peripheral/Systemic Lymphoma;AIDS-related Primary CNS Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Blastic Phase Chronic Myelogenous Leukemia;Childhood Myelodysplastic Syndromes;Chronic Eosinophilic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Gastrointestinal Stromal Tumor;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Meningeal Chronic Myelogenous Leukemia;Monoclonal Gammopathy of Undetermined Significance;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Polycythemia Vera;Previously Treated Myelodysplastic Syndromes;Primary Central Nervous System Non-Hodgkin Lymphoma;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Mycosis Fungoides/Sezary Syndrome;Stage IV Small Lymphocytic Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Unspecified Adult Solid Tumor, Protocol Specific;Untreated Adult Acute Lymphoblastic Leukemia;Untreated Adult Acute Myeloid Leukemia;Untreated Hairy Cell Leukemia;Waldenström Macroglobulinemia | Drug: imatinib mesylate;Other: pharmacological study | National Cancer Institute (NCI) | NULL | Completed | 15 Years | N/A | Both | 60 | Phase 1 | United States |
| 249 | NCT00224393 (ClinicalTrials.gov) | February 2001 | 21/9/2005 | Phase II Trial of Enbrel in Patients With Primary Systemic Amyloidosis | Primary Systemic Amyloidosis | Drug: Enbrel | The Cleveland Clinic | NULL | Suspended | 18 Years | N/A | Both | 60 | Phase 2 | NULL | |
| 250 | NCT00014235 (ClinicalTrials.gov) | December 2000 | 10/4/2001 | Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies | Nonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based Immunosuppression | Acute Myeloid Leukemia/Transient Myeloproliferative Disorder;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Blastic Plasmacytoid Dendritic Cell Neoplasm;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage II Multiple Myeloma;Stage III Multiple Myeloma;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Untreated Adult Acute Lymphoblastic Leukemia;Untreated Adult Acute Myeloid Leukemia;Untreated Childhood Acute Lymphoblastic Leukemia;Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies;Waldenström Macroglobulinemia | Drug: fludarabine phosphate;Radiation: total-body irradiation;Procedure: peripheral blood stem cell transplantation;Procedure: allogeneic hematopoietic stem cell transplantation;Drug: cyclosporine;Drug: mycophenolate mofetil;Other: laboratory biomarker analysis | Fred Hutchinson Cancer Research Center | National Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI) | Completed | N/A | 74 Years | All | 160 | N/A | United States;Germany;Italy |
| 251 | NCT00075621 (ClinicalTrials.gov) | August 2000 | 9/1/2004 | Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis | A Phase II Trial of Tandem Transplantation in AL Amyloidosis | Multiple Myeloma | Drug: filgrastim;Drug: melphalan;Procedure: autologous peripheral blood stem cell transplantation | Boston Medical Center | NULL | Completed | 18 Years | 65 Years | All | 62 | Phase 2 | United States |
| 252 | NCT00006251 (ClinicalTrials.gov) | May 2000 | 11/9/2000 | Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer | Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil | Acute Undifferentiated Leukemia;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Renal Cell Cancer;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage II Multiple Myeloma;Stage III Multiple Myeloma;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Waldenström Macroglobulinemia | Radiation: total-body irradiation;Drug: fludarabine phosphate;Drug: cyclosporine;Drug: mycophenolate mofetil;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Biological: donor lymphocytes;Procedure: peripheral blood stem cell transplantation;Other: laboratory biomarker analysis | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Completed | N/A | 74 Years | All | 21 | Phase 1/Phase 2 | United States;Italy;Germany |
| 253 | NCT00344526 (ClinicalTrials.gov) | January 2000 | 22/6/2006 | Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis | Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial . | Primary Systemic Amyloidosis (AL) | Drug: Melphalan;Drug: Dexamethasone;Procedure: Autologous stem cell transplantation | University Hospital, Limoges | Ministry of Health, France | Completed | 18 Years | 70 Years | Both | 100 | Phase 3 | France |
| 254 | NCT00112593 (ClinicalTrials.gov) | November 1999 | 2/6/2005 | Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer | Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil | Accelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aggressive NK-cell Leukemia;AIDS-related Diffuse Large Cell Lymphoma;AIDS-related Diffuse Mixed Cell Lymphoma;AIDS-related Diffuse Small Cleaved Cell Lymphoma;AIDS-related Immunoblastic Large Cell Lymphoma;AIDS-related Lymphoblastic Lymphoma;AIDS-related Peripheral/Systemic Lymphoma;AIDS-related Primary CNS Lymphoma;AIDS-related Small Noncleaved Cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Blastic Phase Chronic Myelogenous Leukemia;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Contiguous Stage II Adult Burkitt Lymphoma;Contiguous Stage II Adult Diffuse Large Cell Lymphoma;Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Contiguous Stage II Adult Lymphoblastic Lymphoma;Contiguous Stage II Grade 1 Follicular Lymphoma;Contiguous Stage II Grade 2 Follicular Lymphoma;Contiguous Stage II Grade 3 Follicular Lymphoma;Contiguous Stage II Mantle Cell Lymphoma;Contiguous Stage II Marginal Zone Lymphoma;Contiguous Stage II Small Lymphocytic Lymphoma;Cutaneous B-cell Non-Hodgkin Lymphoma;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;HIV Infection;HIV-associated Hodgkin Lymphoma;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Meningeal Chronic Myelogenous Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Central Nervous System Lymphoma;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage 0 Chronic Lymphocytic Leukemia;Stage I Adult Burkitt Lymphoma;Stage I Adult Diffuse Large Cell Lymphoma;Stage I Adult Diffuse Mixed Cell Lymphoma;Stage I Adult Diffuse Small Cleaved Cell Lymphoma;Stage I Adult Hodgkin Lymphoma;Stage I Adult Immunoblastic Large Cell Lymphoma;Stage I Adult Lymphoblastic Lymphoma;Stage I Adult T-cell Leukemia/Lymphoma;Stage I Childhood Anaplastic Large Cell Lymphoma;Stage I Childhood Hodgkin Lymphoma;Stage I Childhood Large Cell Lymphoma;Stage I Childhood Lymphoblastic Lymphoma;Stage I Childhood Small Noncleaved Cell Lymphoma;Stage I Chronic Lymphocytic Leukemia;Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;Stage I Grade 1 Follicular Lymphoma;Stage I Grade 2 Follicular Lymphoma;Stage I Grade 3 Follicular Lymphoma;Stage I Mantle Cell Lymphoma;Stage I Marginal Zone Lymphoma;Stage I Multiple Myeloma;Stage I Small Lymphocytic Lymphoma;Stage IA Mycosis Fungoides/Sezary Syndrome;Stage IB Mycosis Fungoides/Sezary Syndrome;Stage II Adult Hodgkin Lymphoma;Stage II Adult T-cell Leukemia/Lymphoma;Stage II Childhood Anaplastic Large Cell Lymphoma;Stage II Childhood Hodgkin Lymphoma;Stage II Childhood Large Cell Lymphoma;Stage II Childhood Lymphoblastic Lymphoma;Stage II Childhood Small Noncleaved Cell Lymphoma;Stage II Chronic Lymphocytic Leukemia;Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;Stage II Multiple Myeloma;Stage IIA Mycosis Fungoides/Sezary Syndrome;Stage IIB Mycosis Fungoides/Sezary Syndrome;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Hodgkin Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Adult T-cell Leukemia/Lymphoma;Stage III Childhood Anaplastic Large Cell Lymphoma;Stage III Childhood Hodgkin Lymphoma;Stage III Childhood Large Cell Lymphoma;Stage III Childhood Lymphoblastic Lymphoma;Stage III Childhood Small Noncleaved Cell Lymphoma;Stage III Chronic Lymphocytic Leukemia;Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Small Lymphocytic Lymphoma;Stage IIIA Mycosis Fungoides/Sezary Syndrome;Stage IIIB Mycosis Fungoides/Sezary Syndrome;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Childhood Anaplastic Large Cell Lymphoma;Stage IV Childhood Hodgkin Lymphoma;Stage IV Childhood Large Cell Lymphoma;Stage IV Childhood Lymphoblastic Lymphoma;Stage IV Childhood Small Noncleaved Cell Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Small Lymphocytic Lymphoma;Stage IVA Mycosis Fungoides/Sezary Syndrome;Stage IVB Mycosis Fungoides/Sezary Syndrome;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström Macroglobulinemia | Drug: fludarabine phosphate;Radiation: total-body irradiation;Procedure: peripheral blood stem cell transplantation;Drug: cyclosporine;Drug: mycophenolate mofetil;Other: laboratory biomarker analysis | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Completed | N/A | 75 Years | All | 5 | N/A | United States |
| 255 | NCT00007995 (ClinicalTrials.gov) | July 1999 | 6/1/2001 | Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis | Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Biological: recombinant interferon alfa;Biological: sargramostim;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Procedure: autologous bone marrow transplantation;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantation | Herbert Irving Comprehensive Cancer Center | National Cancer Institute (NCI) | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 256 | NCT00003853 (ClinicalTrials.gov) | April 1999 | 1/11/1999 | 4'-Iodo-4'-Deoxydoxorubicin in Treating Patients With Primary Systemic Amyloidosis | Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL) | Multiple Myeloma and Plasma Cell Neoplasm | Drug: 4'-iodo-4'-deoxydoxorubicin | National Cancer Institute (NCI) | NULL | Completed | 18 Years | N/A | Both | 45 | Phase 2 | United States;Italy |
| 257 | NCT00003353 (ClinicalTrials.gov) | July 1998 | 1/11/1999 | High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic Amyloidosis | A Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantation | Eastern Cooperative Oncology Group | National Cancer Institute (NCI) | Completed | 18 Years | 70 Years | Both | Phase 2 | United States | |
| 258 | NCT00002849 (ClinicalTrials.gov) | November 1996 | 1/11/1999 | S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis | Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis | Multiple Myeloma | Biological: recombinant interferon alfa;Drug: dexamethasone | Southwest Oncology Group | National Cancer Institute (NCI);Cancer and Leukemia Group B | Completed | 18 Years | N/A | Both | 93 | Phase 2 | United States |
| 259 | EUCTR2017-005115-13-GB (EUCTR) | 06/03/2018 | A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 Other descriptive name: Inotersen | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 164 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom | |||
| 260 | EUCTR2017-005115-13-FR (EUCTR) | 27/02/2018 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 | Familial Amyloid Polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Human Transthyretin Antisense Oligonucleotide Product Code: ISIS 420915 INN or Proposed INN: ISIS 420915 Other descriptive name: Inotersen | Ionis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 164 | Phase 3 | Portugal;United States;France;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom | |||
| 261 | EUCTR2018-004670-10-NL (EUCTR) | 03/02/2021 | Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) | Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN) MedDRA version: 20.0;Level: LLT;Classification code 10057949;Term: Familial amyloid polyneuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AG10 Product Code: AG10 HCl INN or Proposed INN: AG10 HCl Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID | Eidos Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | Portugal;Serbia;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Netherlands;Germany;New Zealand |