COMPLETE REMISSION INDUCTION WITH COMBINED VBMCP CHEMOTHERAPY AND INTERFERON (RIFN(ALPHA-2B)) IN PATIENTS WITH MULTIPLE-MYELOMA

The purpose of this study was to evaluate a new regimen for the treatm ent of multiple myeloma based on alternating 3-week cycles of chemothe rapy and interferon (rIFN(alpha 2)). In this prospective phase II clin ical trial the Eastern Cooperative Oncology Group evaluated a regimen consisting of 2 cycles of VBMCP (Vincristine 1.2 mg/M(2) IV d1, BCNU 2 0 mg/M(2) IV d1, Melphalan 8 mg/M(2) PO d1-4, Cyclophosphamide 400 m/M (2) IV d1, Prednisone 40 mg/M(2) PO d1-7) followed by alternating 3-we ek cycles of VBMCP and rIFN(alpha 2) 5Mu/M(2) SC 3x/week. Treatment wa s administered for 2 years. Fifty-eight patients with previously untre ated multiple myeloma were entered, Objective response (OR) required 5 0% decrease in M-protein with correction of severe anemia and no progr ession of skeletal disease. Complete remission (CR) was defined by dis appearance of M-protein and normalization of the bone marrow morpholog y. Life table analysis was utilized to express survival and response d uration. Fifty-four patients were evaluable. Objective response was se en in 80% of patients including CR in 30% (16 patients), The median re sponse duration is 35 months, 46 months for patients with CR. The medi an survival is 42 months for all patients. Five year survival is 42%. Although 78% of patients had neutrophil nadirs <1000 x 10(9)/L, the in cidence of severe infection was only 9%. These data demonstrate that V BMCP + interferon is an effective new regimen combining chemotherapy w ith a biological response modifier for the treatment of multiple myelo ma. The incidence of CR is high, and the response and survival duratio ns appear to be 1 year longer than usually seen with standard chemothe rapy. A current ECOG randomized trial compares VBMCP + interferon with VBMCP alone.