NCT00008268

Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma

A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan (60 MG/M2) + G-CSF In Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	melphalan

Timeline

• Start date: 2000-08-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2003-01-27
• Last updated: 2013-06-18

Locations

1 site across 1 country: United States