A Multi-Center Phase III Study of Autologous Transplantation for Patients With Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine With Melphalan 200 mg/m2 + Amifostine
I. Compare the complete response (CR) and near CR rate in patients undergoing autologous
stem cell transplant (ASCT) using melphalan 280 mg/m^2 or melphalan 200 mg/m^2.
I. Compare toxicities between patients receiving amifostine and melphalan 280 mg/m^2 or
melphalan 200 mg/m^2.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (HIGH DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine intravenously (IV)
over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on
ARM II (LOW DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine as in arm I and
melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION (PBSCT): At least 20
hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day
Patients undergo restaging of the disease between days 80-90. Patients with progressive
disease are removed from the study. Patients who achieve a CR or near-CR can proceed to
optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo
additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive
disease are removed from the study. Patients without progressive disease can proceed to
After completion of study treatment, patients are followed up every 3 months for 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
CR and near CR rates
Observe a statistically significant difference at the two-sided significance level of .05 with 80% and 90% power for various assumed-true CR rates.
Up to 120 days after transplant
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|VA Puget Sound Health Care System||Seattle, Washington 98101|
|University of Rochester||Rochester, New York 14642|