Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in
PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients
then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood
stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days.
Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC
and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and
continuing until blood counts recover. This course may be repeated 4-12 weeks later.
Patients are followed every 3 months for 1 year and then annually for 5 years.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response, disease-free survial, and overall survial; response will be determined by the change in organ dysfunction
Charles S. Hesdorffer
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
199/15927
NCT00017680
July 1999
April 2004
Name | Location |
---|---|
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |