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Phase III Chemotherapy with Various Combinations of VCR, L-PAM, CTX, BCNU, ADR, PRED, and LEV for Multiple Myeloma
Basic Trial Information
Objectives I. Compare the effects of 4 drug combinations for remission induction in previously untreated patients with multiple myeloma: followed by VBAP: vincristine/BCNU/adriamycin/prednisone vs. VMCP/levamisole followed by VBAP/levamisole vs. VCP: vincristine/cyclophosphamide/prednisone vs. VCP/levamisole. II. Evaluate 12 months of Maintenance chemotherapy with VCP with and without levamisole vs. similar, previous SWOG therapies. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients previously untreated with chemotherapy with measurable disease and objective evidence and symptoms of complications of any stage of multiple myeloma. Asymptomatic patients are entered only if they have a confirmed diagnosis and there is evidence of increasing tumor mass. Patients must have an adequate cardiac status. Expected Enrollment 266 patients will be entered in just over 18 months. Protocol closed August 1982. Outline Randomized study for Induction only. Randomize patients to Arms I, II, III and IV at the ratio of 1:2:2:2 respectively. Induction: Arm I: Sequential 3-Drug Combination Chemotherapy plus Hormone Therapy. VMCP: Vincristine, VCR, NSC-67574; Melphalan, L-PAM, NSC-8806; Cyclophosphamide, CTX, NSC-26271; plus Prednisone, PRED, NSC-10023; followed by VBAP: VCR; BCNU, NSC-409962; Adriamycin, ADR, NSC-123127; plus PRED. Arm II: Sequential 3-Drug Combination Chemotherapy, Hormone Therapy plus Immunotherapy. VMCP; plus Levamisole, LEV, NSC-177023; followed by VBAP plus LEV. Induction and Maintenance: Arm III: 2-Drug Combination Chemotherapy plus Hormone Therapy. VCP: VCR; CTX; plus PRED. Arm IV: 2-Drug Combination Chemotherapy plus Hormone Therapy plus Immunotherapy. VCP; plus LEV.Published Results Durie BG, Dixon DO, Carter S, et al.: Improved survival duration with combination chemotherapy induction for multiple myeloma: a Southwest Oncology Group Study. J Clin Oncol 4 (8): 1227-37, 1986.[PUBMED Abstract] Trial Lead Organizations Southwest Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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