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The Treatment of Multiple Myeloma Utilizing Vincristine, Carmustine (BCNU), Melphalan, Cyclophosphamide, and Prednisone (VBMCP) Alternating with High-Dose Cyclophosphamide and Alpha2 Beta-Interferon Versus VBMCP: Results of a Phase III Eastern Cooperative Oncology Group Study E5A93 #MMPMID19248045
Cancer 2009[May]; 115 (10): 2155-64 PMID19248045show ga
Background: A randomized controlled trial to test the hypothesis that aggressive initial therapy utilizing high-dose cyclophosphamide and alpha-2-interferon may be superior to standard combination alkylating agent regimens in the treatment of newly diagnosed myeloma. Methods: This Eastern Cooperative Oncology Group trial evaluated 268 previously untreated patients with active multiple myeloma randomized to vincristine, carmustine (BCNU), melphalan, cyclophosphamide and prednisone (VBMCP) or VBMCP plus high-dose cyclophosphamide (HiCy) and recombinant ?2? interferon (IFN). Results: The overall objective response was 62% in the VBMCP regimen and 68% in the VBMCP + HiCy + IFN group. The near complete response (NCR) and complete response (CR) rates were 8.1% and 8.9%, respectively. Progression-free survival (PFS) was 22.1 and 25.3 months, respectively. The median overall survival (OS) for patients treated with VBMCP was 37.1 months and 41.3 months for those treated with VBMCP + HiCy + IFN (P=0.38). The 5-year overall survival rates were not significantly different between the two arms, 26.4% and 33%, respectively. Lethal toxicities occurred in 15 patients, including 10 from infection, but there was no significant difference in lethal toxicities between the two regimens. Conclusion: The study showed no significant benefit with the addition of high-dose cyclophosphamide and alpha-2 interferon to VBMCP.