28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
| 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 | JPRN-jRCT2031220037 | 20/06/2022 | 23/04/2022 | 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 - AFFIRM-AL | Light Chain (AL) Amyloidosis | - Birtamimab group: Intravenous administration of 24 mg/kg birtamimab every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy - Placebo group: Intravenous 0.9% Saline administration as a placebo every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy | Nie Christie | NULL | Recruiting | >= 18age old | Not applicable | Both | 16 | Phase 3 | Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Republic of Korea;Netherlands;New Zealand;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;United States;Japan |
| 2 | 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 | ||
| 3 | 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 |
| 4 | NCT04504825 (ClinicalTrials.gov) | February 2, 2021 | 20/7/2020 | A Study to Evaluate the Efficacy 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 | Alexion | NULL | Recruiting | 18 Years | N/A | All | 124 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Switzerland;United Kingdom |
| 5 | NCT04512235 (ClinicalTrials.gov) | November 12, 2020 | 10/8/2020 | A Study to Evaluate the Efficacy 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 | Alexion | NULL | Recruiting | 18 Years | N/A | All | 267 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 6 | 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: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: Daratumumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 bonemarrow 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 dysfunctionof 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 | Not Recruiting | Female: yes Male: yes | 120 | Phase 2;Phase 3 | Canada;Turkey;Germany;Italy | ||
| 13 | 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 | Active, not recruiting | 18 Years | N/A | All | 19 | Phase 2/Phase 3 | Canada;France;Germany;Greece;Italy;Spain;Turkey;United Kingdom |
| 14 | 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 | ||
| 15 | 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 | United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of;Sweden | ||
| 16 | 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 | ||
| 17 | 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 4 | Japan, Asia except Japan, North America, Europe | |
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 |
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | Phase 3 | United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of;Sweden | ||
| 27 | 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 | Canada;China;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;United Kingdom;United States;Romania;Australia;Belgium;Brazil |
| 28 | 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 | |
| 29 | 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 | |
| 30 | 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 |
| 31 | 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 | ||
| 32 | 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 |
| 33 | 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 |
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | |||
| 39 | 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 | ||
| 40 | 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. | 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. - BMD treatment 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 |
| 41 | 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 | ||
| 42 | 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 |
| 43 | 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 | ||
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 | ||
| 48 | 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 | |||
| 49 | 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 |
| 50 | 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 |
| 51 | 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 |
| 52 | 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 |
| 53 | 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 |
| 54 | 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 |
| 55 | 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 |