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

  
17 trials found
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2018-004333-33-FR
(EUCTR)
23/01/202002/12/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 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 NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
2EUCTR2018-004333-33-IT
(EUCTR)
01/08/201928/04/2020Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 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 NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
3EUCTR2018-004333-33-NL
(EUCTR)
24/07/201908/07/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 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 NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
4EUCTR2018-004333-33-GR
(EUCTR)
08/07/201905/06/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 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 NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
5EUCTR2010-022395-31-CZ
(EUCTR)
01/10/201317/07/2013A 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 NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
6EUCTR2010-022395-31-DE
(EUCTR)
25/10/201218/10/2012Clinical trial of Melphalan and Dexamethasone versus Bortezomib, Melphalan and Dexamethasone for untreated patients with systemic light-chain (AL) amyloidosisA 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 NetworkNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;Czech Republic;Greece;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
7EUCTR2010-022395-31-ES
(EUCTR)
13/06/201221/05/2012A 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) amyloidosisA 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 NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Germany;Netherlands;Denmark;Norway;France;Spain;Italy;Greece;Sweden
8EUCTR2010-021445-42-BE
(EUCTR)
10/05/201210/10/2011A 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 FoundationNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
9EUCTR2010-021445-42-DE
(EUCTR)
09/05/201223/01/2012A study to investigated whether bortezomib is effective in patients with AL amyloidosisA 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 FoundationNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Belgium;Netherlands;Germany
10EUCTR2010-022395-31-GR
(EUCTR)
02/05/201202/04/2012N/AN/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 NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110United Kingdom;Denmark;Spain;Italy;Greece;Sweden;Australia
11EUCTR2010-022395-31-DK
(EUCTR)
14/11/201109/06/2011A 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 NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
12EUCTR2010-021445-42-NL
(EUCTR)
31/08/201127/01/2011A study in which is investigated if the medicine bortezomib is effective in patients with AL amyloidosisA 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 FoundationNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
13EUCTR2010-022395-31-SE
(EUCTR)
10/06/201112/04/2011A 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 NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Denmark;Spain;Italy;Greece;Sweden
14EUCTR2010-022395-31-IT
(EUCTR)
07/10/201001/12/2010A 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 - NDA 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 NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
15EUCTR2009-014906-33-GB
(EUCTR)
17/09/201018/06/2010A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEALA 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 LondonNULLNot RecruitingFemale: yes
Male: yes
52United Kingdom
16NCT00520767
(ClinicalTrials.gov)
September 200724/8/2007Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition DiseaseA Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition DiseasePrimary Systemic Amyloidosis;Light Chain Deposition DiseaseDrug: bortezomib;Drug: dexamethasone;Drug: melphalan;Genetic: microarray analysis;Other: flow cytometry;Other: laboratory biomarker analysis;Procedure: quality-of-life assessmentBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 Years120 YearsAll35Phase 2United States
17EUCTR2004-004871-12-IT
(EUCTR)
02/05/200507/06/2005An Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-AmyloidosisAn 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-CILAGNULLNot RecruitingFemale: yes
Male: yes
Phase 1/2Italy