MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL

OBJECTIVES: I. Compare survival of patients under age 65 with myeloma treated with standard ABCM (doxorubicin, carmustine, cyclophosphamide, melphalan) vs. intensive C-VAMP (cyclophosphamide, vincristine, doxorubicin, methylprednisolone) followed by high-dose melphalan (with or without total-body irradiation) with bone marrow and peripheral blood stem cell support, both with IFN-A maintenance. II. Compare the toxicity profiles of the 2 treatment arms. III. Compare the 2 treatment arms with respect to quality of life and health economics issues. IV. Investigate cellular changes by means of linked morphology, phenotype, and cytogenetics studies before and after treatment and at relapse. OUTLINE: Randomized study. The following acronyms are used: ABM Autologous Bone Marrow BCNU Carmustine, NSC-409962 CTX Cyclophosphamide, NSC-26271 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony Stimulating Factor (Amgen), NSC-614629 GM-CSF Granulocyte-Macrophage Colony Stimulating Factor (source not specified) IFN-A Interferon alpha (Hoffmann-La Roche), NSC-367982 L-PAM Melphalan, NSC-8806 MePRDL Methylprednisolone, NSC-19987 PBSC Peripheral Blood Stem Cells PRED Prednisone, NSC-10023 TBI Total-Body Irradiation VCR Vincristine, NSC-67574 ARM I. Induction: 4-Drug Combination Chemotherapy or, as indicated, 2-Drug Combination Chemotherapy. ABCM: DOX; BCNU; CTX; L-PAM; or, if pretreatment ANC and platelets are less than 1,300 and 75,000, CTX; PRED. Maintenance: Biological Response Modifier Therapy. IFN-A. ARM II. Induction: 4-Drug Combination Chemotherapy followed by Hematopoietic Stimulation. C-VAMP: DOX; VCR; MePRDL; CTX; followed by CTX; G-CSF or GM-CSF. Consolidation: 3-Drug Combination Chemoablation with or without Radioablation followed by Hematopoietic Rescue. CTX; L-PAM; MePRDL; with or without TBI using megavoltage equipment (linear accelerator preferred); followed by ABM and/or PBSC. Maintenance: Biological Response Modifier Therapy. IFN-A. PROJECTED ACCRUAL: 750 patients will be accrued.