HIGH-DOSE MELPHALAN CHEMOTHERAPY AND TOTAL BODY RADIATION WITH PERIPHERAL BLOOD STEM-CELL RECONSTITUTION FOR PATIENTS WITH RELAPSING MULTIPLE MYELOMA
OBJECTIVES: I. Assess bone marrow reconstitution and peripheral blood cell counts of
patients with multiple myeloma treated with high-dose melphalan (L-PAM) and total-body
irradiation (TBI) followed by peripheral blood stem cell (PBSC) rescue. II. Assess the
efficacy of intravenous L-PAM and TBI for treatment of relapsing/refractory myeloma. III.
Assess the tolerability and toxicity of this regimen in patients with relapsing multiple
myeloma. IV. Assess response rate and survival of relapsing/refractory patients treated with
this regimen.
OUTLINE: Prior to entry, patients will have received 3 monthly courses of standard VAD
followed by PBSC collection on Regimen A; those who responded to VAD continue standard VAD
to best response and upon relapse (on or off therapy) proceed to Regimen B. Patients with no
response to 3 courses of VAD and those with no response to an alkylating-based regimen
proceed immediately to Regimen B following PBSC collection. The following acronyms are used:
CTX Cyclophosphamide, NSC-26271 G-CSF Granulocyte Colony Stimulating Factor (Amgen),
NSC-614629 L-PAM Melphalan, NSC-8806 PBSC Peripheral Blood Stem Cells VAD
Vincristine/Doxorubicin/Dexamethasone TBI Total Body Irradiation Regimen A: Stem Cell
Mobilization/Harvest. CTX; G-CSF. Regimen B: Single-Agent Myeloablative Chemoradiotherapy
with Stem Cell Rescue. L-PAM; TBI (Co60 or linear accelerators of 4 MV or greater); with
PBSC.
PROJECTED ACCRUAL: If 9 or fewer or 20 or more responses are seen in the first 50 patients
treated, the study will be discontinued.
Interventional
Primary Purpose: Treatment
Morie A. Gertz, MD
Study Chair
Mayo Clinic
United States: Food and Drug Administration
CDR0000064030
NCT00002630
June 1993
May 2001
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |