High-Dose Melphalan Followed by Peripheral Stem Cell Transplant in Treating Patients With Amyloidosis
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.
PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with peripheral stem cell transplant works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL)|
- Overall survival [ Designated as safety issue: No ]
- Time to clinical progression of amyloid symptoms [ Designated as safety issue: No ]
|Study Start Date:||May 1996|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
- Assess overall and progression-free survival following high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with primary amyloidosis.
- Evaluate the toxic effects associated with this treatment regimen.
- Evaluate the function of involved organs, especially the heart, lungs, and nervous system, before and after treatment with this regimen.
OUTLINE: Peripheral blood stem cells (PBSC) are mobilized with granulocyte colony-stimulating factor (G-CSF) for 5 days and then collected by leukapheresis. Patients receive high-dose melphalan on 2 consecutive days, followed by 1 day of rest, then by PBSC transplantation. G-CSF is given from 1 day after transplantation until the neutrophil count is greater than 1,500 for 3 consecutive days.
Patients are followed at 100 days and 1 year post-transplant.
PROJECTED ACCRUAL: A very small number of patients are expected to be accrued over 5-10 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002810
|United States, Pennsylvania|
|Fox Chase-Temple Cancer Center CCOP Research Base|
|Philadelphia, Pennsylvania, United States, 19111-2442|
|Study Chair:||Kenneth F. Mangan, MD, FACP||Fox Chase Cancer Center|