A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

OBJECTIVES: * Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone. * Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens. * Compare the quality of life of patients treated with these 2 regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only. * Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I. Patients without a maximal response after completion of course 4 may receive up to 2 additional courses. Quality of life is assessed at baseline and then prior to each study course. Patients are followed for survival. PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.