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 | NCT04115956 (ClinicalTrials.gov) | August 6, 2020 | 29/8/2019 | A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy | AL Amyloidosis | Drug: Melphalan-Flufenamide (Melflufen);Drug: Dexamethasone | Oncopeptides AB | PRA Health Sciences | Terminated | 18 Years | N/A | All | 6 | Phase 1/Phase 2 | United States;Czechia;France;Germany;Greece;Israel;Norway;Spain;United Kingdom;Italy;Poland |
| 2 | EUCTR2018-002761-19-DE (EUCTR) | 06/03/2020 | 12/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2018-002761-19-ES (EUCTR) | 05/02/2020 | 09/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis.Patients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-002761-19-GR (EUCTR) | 03/12/2019 | 15/11/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2018-002761-19-NO (EUCTR) | 15/11/2019 | 01/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy | ||
| 6 | EUCTR2018-002761-19-IT (EUCTR) | 25/10/2019 | 29/01/2021 | It is an early clinical trial to assess a new drug (Melflufen) when given together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis. Patients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy - NA | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen Product Code: [Melflufen] INN or Proposed INN: melphalan fulfenamide hydrochloride Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: [H02AB02] INN or Proposed INN: DESAMETASONE | ONCOPEPTIDES AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2018-002761-19-PL (EUCTR) | 24/10/2019 | 07/08/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2018-002761-19-CZ (EUCTR) | 21/10/2019 | 31/07/2019 | It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy | Patients with AL Amyloidosis MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Melflufen INN or Proposed INN: melphalan fulfenamide hydrochloride Other descriptive name: MELFLUFEN Trade Name: Dexamethasone 4 mg JENAPHARM Product Name: Dexamethasone Product Code: H02AB02 INN or Proposed INN: DEXAMETHASONE | Oncopeptides AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom | ||
| 9 | 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 |
| 10 | NCT01807286 (ClinicalTrials.gov) | January 2014 | 6/3/2013 | Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis | A Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase I | Myeloma | Drug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: Questionnaires | M.D. Anderson Cancer Center | Celgene | Terminated | 18 Years | N/A | Both | 3 | Phase 1 | United States |
| 11 | 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 | ||
| 12 | 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 |
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | |||
| 18 | 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 | ||
| 19 | 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 |
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 |
| 23 | 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 |
| 24 | 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 | ||
| 25 | 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 |
| 26 | NCT00890552 (ClinicalTrials.gov) | April 2009 | 28/4/2009 | A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis | A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis | Leukemia;Amyloidosis | Drug: Lenalidomide;Drug: Melphalan;Drug: Dexamethasone | Stanford University | Celgene Corporation | Completed | 18 Years | N/A | All | 25 | N/A | United States |
| 27 | NCT00883623 (ClinicalTrials.gov) | April 2009 | 15/4/2009 | A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis | A Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL Amyloidosis | Primary Amyloidosis | Drug: Lenalidomide | Heidelberg University | Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH | Completed | 18 Years | 74 Years | Both | 50 | Phase 2 | Germany |
| 28 | EUCTR2008-001405-41-DE (EUCTR) | 24/10/2008 | 28/08/2008 | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | AL amyloidosis | Trade Name: Revlimid Other descriptive name: Lenalidomide Trade Name: Alkeran Product Code: L01AA03 Other descriptive name: melphalan Trade Name: Fortecortin Other descriptive name: dexamethasone | GMIHO mbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 29 | 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 |
| 30 | NCT00679367 (ClinicalTrials.gov) | May 2008 | 14/5/2008 | Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis | A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis | Multiple Myeloma | Drug: dexamethasone;Drug: lenalidomide;Drug: melphalan | Boston Medical Center | NULL | Completed | 18 Years | N/A | All | 16 | Phase 2 | United States |
| 31 | 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 |
| 32 | EUCTR2006-006395-37-GB (EUCTR) | 06/09/2007 | 31/07/2007 | A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) | A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) | The medical condition to be investigated is systemic AL Amyloidosis, a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function. MedDRA version: 9.1;Level: LLT;Classification code 10002022;Term: Amyloidosis | Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Product Name: Dexamethasone INN or Proposed INN: DEXAMETHASONE Product Name: Dexamethasone INN or Proposed INN: DEXAMETHASONE Trade Name: Lenogastrim Other descriptive name: GRANULOCYTE COLONY STIMULATING FACTOR Product Name: Melphalan INN or Proposed INN: MELPHALAN | Joint UCLH and UCL Biomedical Research Unit | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 33 | 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 |
| 34 | 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 |
| 35 | NCT00536601 (ClinicalTrials.gov) | June 29, 2006 | 27/9/2007 | High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors | Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors | Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET);Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Nodal Marginal Zone B-cell Lymphoma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Malignant Testicular Germ Cell Tumor;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Neuroblastoma;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Regional Neuroblastoma;Splenic Marginal Zone Lymphoma;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström Macroglobulinemia | Drug: etoposide;Drug: cyclophosphamide;Drug: carmustine;Drug: melphalan;Drug: busulfan;Drug: carboplatin;Drug: thiotepa;Radiation: total-body irradiation;Procedure: autologous hematopoietic stem cell transplantation;Procedure: autologous-autologous tandem hematopoietic stem cell transplantation | Roswell Park Cancer Institute | National Cancer Institute (NCI) | Completed | 4 Years | N/A | All | 174 | N/A | United States |
| 36 | NCT00477971 (ClinicalTrials.gov) | October 2005 | 23/5/2007 | Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis | Phase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL) | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: dexamethasone;Drug: melphalan;Procedure: autologous hematopoietic stem cell transplantation | Mayo Clinic | National Cancer Institute (NCI) | Completed | 18 Years | N/A | All | 89 | Phase 3 | United States |
| 37 | NCT00064337 (ClinicalTrials.gov) | January 2004 | 8/7/2003 | S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis | S0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study) | Multiple Myeloma;Plasma Cell Myeloma | Biological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantation | Southwest Oncology Group | National Cancer Institute (NCI) | Completed | 18 Years | 120 Years | All | 104 | Phase 2 | United States |
| 38 | NCT00052884 (ClinicalTrials.gov) | October 2003 | 24/1/2003 | Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation | A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis | Drug/Agent Toxicity by Tissue/Organ;Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: amifostine trihydrate;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantation | Eastern Cooperative Oncology Group | National Cancer Institute (NCI) | Terminated | 18 Years | 70 Years | Both | 8 | Phase 1 | United States |
| 39 | NCT01527032 (ClinicalTrials.gov) | September 2002 | 28/7/2011 | Risk-adapted Therapy for Primary Systemic (AL) Amyloidosis | Risk-adapted Therapy for AL Amyloidosis | Amyloidosis | Drug: melphalan, thalidomide and dexamethasone | FDA Office of Orphan Products Development | NULL | Completed | Phase 2 | NULL | ||||
| 40 | NCT00089167 (ClinicalTrials.gov) | May 2002 | 4/8/2004 | Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis | Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide | Memorial Sloan Kettering Cancer Center. | National Cancer Institute (NCI) | Completed | 18 Years | N/A | Both | Phase 2 | United States | |
| 41 | NCT00075608 (ClinicalTrials.gov) | August 2001 | 9/1/2004 | 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis | Phase II Trial of Second Autologous Transplantation in AL Amyloidosis | Multiple Myeloma;Plasma Cell Neoplasm | Biological: filgrastim;Drug: melphalan;Procedure: autologous stem cell transplantation;Procedure: stem cell infusion | Boston Medical Center | NULL | Terminated | 18 Years | 65 Years | All | 12 | Phase 2 | United States |
| 42 | NCT00075621 (ClinicalTrials.gov) | August 2000 | 9/1/2004 | Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis | A Phase II Trial of Tandem Transplantation in AL Amyloidosis | Multiple Myeloma | Drug: filgrastim;Drug: melphalan;Procedure: autologous peripheral blood stem cell transplantation | Boston Medical Center | NULL | Completed | 18 Years | 65 Years | All | 62 | Phase 2 | United States |
| 43 | NCT00344526 (ClinicalTrials.gov) | January 2000 | 22/6/2006 | Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis | Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial . | Primary Systemic Amyloidosis (AL) | Drug: Melphalan;Drug: Dexamethasone;Procedure: Autologous stem cell transplantation | University Hospital, Limoges | Ministry of Health, France | Completed | 18 Years | 70 Years | Both | 100 | Phase 3 | France |
| 44 | NCT00007995 (ClinicalTrials.gov) | July 1999 | 6/1/2001 | Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis | Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Biological: recombinant interferon alfa;Biological: sargramostim;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Procedure: autologous bone marrow transplantation;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantation | Herbert Irving Comprehensive Cancer Center | National Cancer Institute (NCI) | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 45 | NCT00003353 (ClinicalTrials.gov) | July 1998 | 1/11/1999 | High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic Amyloidosis | A Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantation | Eastern Cooperative Oncology Group | National Cancer Institute (NCI) | Completed | 18 Years | 70 Years | Both | Phase 2 | United States |