Publication

Abstract : Background The combination of lenalidomide and dexamethasone has been shown to be highly effective in newly diagnosed and relapse multiple myeloma patients. In combination high dose dexamethasone shown to has higher toxicity and low overall survival rate. Addition of a third agent to this combination may increase the response rate at the cost of toxicity. In a phase II trial of lenalidomide cyclophosphamide and dexamethasone shown to has higher response rate but toxicity was also high. We report the results from combining low dose lenalidome, cyclophosphamide and prednisolone in newly diagnosed and relapsed multiple myeloma patients. Methods Trial was initiated in August 2008, the treatment protocol consisted of lenalidomide given orally at a dose of 10 mg daily on days 1-21 of a 28 day cycle. Prednisolone given at a dose of 2mg/kg (max 100 mg) daily for 4 days of each cycle. Cyclophosphamide at a dose of 300 mg (fi xed dose) was given on days 1, 8, and 15 of each cycle. After achievement of maximum response, two more cycles were given. Patients also received an aspirin once daily as thromboprophylaxis. Response was defi ned as per modifi ed EBMT criteria. The study was approved by institutional ethics committee. Results Total nine patients were enroll. Seven patients had completed the study and available for evaluation. Five patients were newly diagnosed. Two patients were relapsed on thalidomide. (Median time of treatment with thalidome was 2 years). Median age of the patient was 59 years. Five are male and 2 female. In newly diagnose response was very good partial response (VGPR) in 2, partial response (PR) in 2 and minimal response in (MR) 1 patients. Median time for response was 5 cycles (range is 4 to 7 cycle). Out of two relapse patients, one had progression of disease after 2 cycles and other had progression of disease after 3 cycles. Hematological toxicity grade 3 in one patient. Main Non hematological toxicity was fatigue. Conclusion The combination of lenalidomide, cyclophosphamide and dexamethasone has excellent activity in the setting of newly diagnosed myeloma patients. In relapsed patients on thalidomide, may not be effective. This may be due to low dose of lenlidomide in our study. This fi nding needs to be confi rmed in larger number of patients with longer duration of follow up.