Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood.
PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: filgrastim Drug: melphalan||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma|
|Study Start Date:||August 2000|
|Study Completion Date:||June 2003|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
- Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma.
- Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients.
- Determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients.
OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until PBSC collection is complete.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008268
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Raymond L. Comenzo, MD||Memorial Sloan Kettering Cancer Center|