VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE
- Compare the efficacy of doxorubicin, carmustine, cyclophosphamide, and melphalan (ABCM)
with or without oral cyclophosphamide and prednisone as induction for the first plateau
phase in elderly patients with previously untreated multiple myeloma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Patients receive doxorubicin IV followed immediately by carmustine IV over 1-2 hours on day
1 and oral melphalan (L-PAM) and oral cyclophosphamide (CTX) on days 22-25 (ABCM). Treatment
continues every 6 weeks for 3 courses in the absence of disease progression or unacceptable
toxicity. Patients whose blood counts recover within 6 weeks after beginning L-PAM and CTX
during course 3 are randomized to 1 of 2 treatment arms. Patients whose blood counts fail to
recover within 6 weeks after beginning L-PAM and CTX during course 3 are assigned to arm II.
- Arm I: Patients continue ABCM for a maximum of 12 courses in the absence of a plateau
phase after completion of at least 4 courses, disease progression, or unacceptable
- Arm II: Patients receive oral cyclophosphamide once weekly and oral prednisone every
other day. Treatment continues every 6 weeks in the absence of a plateau phase after
completion of 3 courses of ABCM plus a minimum of 8 weeks on arm II or less than 3
courses of ABCM plus 6 months on arm II, disease progression, or unacceptable toxicity.
Patients on both arms with bone pain or failure to respond to chemotherapy may undergo
minimal radiotherapy. Patients achieving plateau phase may enter the MRC trial of interferon
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within
approximately 5 years.
Allocation: Randomized, Primary Purpose: Treatment
M. T. Drayson, MD
MRC Myelomatosis Trials Office
United States: Federal Government