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

  
45 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04115956
(ClinicalTrials.gov)
August 6, 202029/8/2019A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) AmyloidosisAn Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of TherapyAL AmyloidosisDrug: Melphalan-Flufenamide (Melflufen);Drug: DexamethasoneOncopeptides ABPRA Health SciencesTerminated18 YearsN/AAll6Phase 1/Phase 2United States;Czechia;France;Germany;Greece;Israel;Norway;Spain;United Kingdom;Italy;Poland
2EUCTR2018-002761-19-DE
(EUCTR)
06/03/202012/08/2019It 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 ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
3EUCTR2018-002761-19-ES
(EUCTR)
05/02/202009/08/2019It 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 ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 1;Phase 2United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy
4EUCTR2018-002761-19-GR
(EUCTR)
03/12/201915/11/2019It 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 ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
5EUCTR2018-002761-19-NO
(EUCTR)
15/11/201901/08/2019It 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 ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy
6EUCTR2018-002761-19-IT
(EUCTR)
25/10/201929/01/2021It 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 ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 1;Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
7EUCTR2018-002761-19-PL
(EUCTR)
24/10/201907/08/2019It 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 ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
8EUCTR2018-002761-19-CZ
(EUCTR)
21/10/201931/07/2019It 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom
9NCT02489500
(ClinicalTrials.gov)
June 20159/3/2015Trial of High Dose Melphalan/Stem Cell Transplant With or Without BortezomibPhase III Trial of High-dose Melphalan and Stem Cell Transplantation Versus High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL AmyloidosisAL AmyloidosisDrug: Bortezomib;Drug: Melphalan;Drug: Neupogen;Procedure: Stem Cell Collection;Procedure: Stem cell infusionBoston Medical CenterNULLTerminated18 YearsN/AAll3Phase 3United States
10NCT01807286
(ClinicalTrials.gov)
January 20146/3/2013Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL AmyloidosisA Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase IMyelomaDrug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: QuestionnairesM.D. Anderson Cancer CenterCelgeneTerminated18 YearsN/ABoth3Phase 1United States
11EUCTR2010-022395-31-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
12NCT01849783
(ClinicalTrials.gov)
April 4, 20136/5/2013Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple MyelomaSingle Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell MalignancyExtramedullary Plasmacytoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Primary Systemic Amyloidosis;Stage I Multiple Myeloma;Stage II Multiple Myeloma;Stage III Multiple MyelomaDrug: dexamethasone;Drug: cisplatin;Drug: doxorubicin;Drug: cyclophosphamide;Drug: etoposide;Drug: bortezomib;Drug: thalidomide;Drug: melphalan;Procedure: autologous stem cell transplantYogesh JethavaNational Cancer Institute (NCI)Active, not recruiting65 Years85 YearsAll41Phase 2United States
13EUCTR2010-022395-31-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
14EUCTR2010-022395-31-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
15EUCTR2010-021445-42-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
16EUCTR2010-021445-42-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
17EUCTR2010-022395-31-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
18EUCTR2010-022395-31-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
19JPRN-UMIN000006604
2011/11/0124/10/2011Phase 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 HematologyNULLComplete: follow-up complete20years-old65years-oldMale and Female21Phase 1,2Japan
20EUCTR2010-021445-42-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
21EUCTR2010-022395-31-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
22NCT01277016
(ClinicalTrials.gov)
January 201110/1/2011A Trial for 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) AmyloidosisAL AmyloidosisDrug: BMDexEuropean Myeloma NetworkNULLCompleted18 YearsN/AAll110Phase 3Italy
23NCT01078454
(ClinicalTrials.gov)
November 201027/2/2010Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain AmyloidosisA 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 TransplantationLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: melphalan;Drug: dexamethasone;Drug: bortezomibNational Cancer Institute (NCI)NULLCompleted18 YearsN/AAll11Phase 3United States
24EUCTR2010-022395-31-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
25NCT01083316
(ClinicalTrials.gov)
September 20092/11/2009Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) AmyloidosisPhase II Trial of Induction Therapy With Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation in Patients With AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: Dexamethasone;Drug: MelphalanBoston Medical CenterMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll35Phase 2United States
26NCT00890552
(ClinicalTrials.gov)
April 200928/4/2009A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisA Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisLeukemia;AmyloidosisDrug: Lenalidomide;Drug: Melphalan;Drug: DexamethasoneStanford UniversityCelgene CorporationCompleted18 YearsN/AAll25N/AUnited States
27NCT00883623
(ClinicalTrials.gov)
April 200915/4/2009A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) AmyloidosisA Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL AmyloidosisPrimary AmyloidosisDrug: LenalidomideHeidelberg UniversityGesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbHCompleted18 Years74 YearsBoth50Phase 2Germany
28EUCTR2008-001405-41-DE
(EUCTR)
24/10/200828/08/2008A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEXA prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX AL amyloidosisTrade Name: Revlimid
Other descriptive name: Lenalidomide
Trade Name: Alkeran
Product Code: L01AA03
Other descriptive name: melphalan
Trade Name: Fortecortin
Other descriptive name: dexamethasone
GMIHO mbHNULLNot RecruitingFemale: yes
Male: yes
Germany
29NCT00790647
(ClinicalTrials.gov)
June 200812/11/2008Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisPhase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL AmyloidosisMultiple MyelomaBiological: filgrastim;Drug: bortezomib;Drug: melphalan;Procedure: Stem Cell InfusionBoston Medical CenterNULLCompleted18 Years65 YearsAll10Phase 2United States
30NCT00679367
(ClinicalTrials.gov)
May 200814/5/2008Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomide;Drug: melphalanBoston Medical CenterNULLCompleted18 YearsN/AAll16Phase 2United States
31NCT01998503
(ClinicalTrials.gov)
December 200715/11/2013Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL AmyloidosisInduction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: dexamethasone;Biological: filgrastim;Procedure: autologous hematopoietic stem cell transplantation (ASCT);Drug: MelphalanNanjing University School of MedicineNULLCompleted18 Years65 YearsBoth56Phase 3China
32EUCTR2006-006395-37-GB
(EUCTR)
06/09/200731/07/2007A 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 UnitNULLNot 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): noUnited Kingdom
33NCT00520767
(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
34NCT00458822
(ClinicalTrials.gov)
February 20079/4/2007Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic AmyloidosisRisk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: bortezomib;Drug: dexamethasoneMemorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed18 Years70 YearsAll40Phase 2United States
35NCT00536601
(ClinicalTrials.gov)
June 29, 200627/9/2007High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid TumorsAutologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid TumorsAdult 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 MacroglobulinemiaDrug: 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 transplantationRoswell Park Cancer InstituteNational Cancer Institute (NCI)Completed4 YearsN/AAll174N/AUnited States
36NCT00477971
(ClinicalTrials.gov)
October 200523/5/2007Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisPhase 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 NeoplasmBiological: filgrastim;Drug: dexamethasone;Drug: melphalan;Procedure: autologous hematopoietic stem cell transplantationMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll89Phase 3United States
37NCT00064337
(ClinicalTrials.gov)
January 20048/7/2003S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic AmyloidosisS0115, 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 MyelomaBiological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantationSouthwest Oncology GroupNational Cancer Institute (NCI)Completed18 Years120 YearsAll104Phase 2United States
38NCT00052884
(ClinicalTrials.gov)
October 200324/1/2003Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell TransplantationA Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic AmyloidosisDrug/Agent Toxicity by Tissue/Organ;Multiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: amifostine trihydrate;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantationEastern Cooperative Oncology GroupNational Cancer Institute (NCI)Terminated18 Years70 YearsBoth8Phase 1United States
39NCT01527032
(ClinicalTrials.gov)
September 200228/7/2011Risk-adapted Therapy for Primary Systemic (AL) AmyloidosisRisk-adapted Therapy for AL AmyloidosisAmyloidosisDrug: melphalan, thalidomide and dexamethasoneFDA Office of Orphan Products DevelopmentNULLCompletedPhase 2NULL
40NCT00089167
(ClinicalTrials.gov)
May 20024/8/2004Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic AmyloidosisRisk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: dexamethasone;Drug: melphalan;Drug: thalidomideMemorial Sloan Kettering Cancer Center.National Cancer Institute (NCI)Completed18 YearsN/ABothPhase 2United States
41NCT00075608
(ClinicalTrials.gov)
August 20019/1/20042nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) AmyloidosisPhase II Trial of Second Autologous Transplantation in AL AmyloidosisMultiple Myeloma;Plasma Cell NeoplasmBiological: filgrastim;Drug: melphalan;Procedure: autologous stem cell transplantation;Procedure: stem cell infusionBoston Medical CenterNULLTerminated18 Years65 YearsAll12Phase 2United States
42NCT00075621
(ClinicalTrials.gov)
August 20009/1/2004Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) AmyloidosisA Phase II Trial of Tandem Transplantation in AL AmyloidosisMultiple MyelomaDrug: filgrastim;Drug: melphalan;Procedure: autologous peripheral blood stem cell transplantationBoston Medical CenterNULLCompleted18 Years65 YearsAll62Phase 2United States
43NCT00344526
(ClinicalTrials.gov)
January 200022/6/2006Intensive Versus Conventional Treatment in Patients With Primary AmyloidosisAutologous 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 transplantationUniversity Hospital, LimogesMinistry of Health, FranceCompleted18 Years70 YearsBoth100Phase 3France
44NCT00007995
(ClinicalTrials.gov)
July 19996/1/2001Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic AmyloidosisPhase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: 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 transplantationHerbert Irving Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed18 YearsN/ABoth75Phase 2United States
45NCT00003353
(ClinicalTrials.gov)
July 19981/11/1999High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic AmyloidosisA Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantationEastern Cooperative Oncology GroupNational Cancer Institute (NCI)Completed18 Years70 YearsBothPhase 2United States