28. Systemic amyloidosis Clinical trials / Disease details
Clinical trials : 261 / Drugs : 276 - (DrugBank : 81) / Drug target genes : 68 - Drug target pathways : 178
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 |
| 2 | 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 |
| 3 | 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 | ||
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 | |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |