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| |  Lenalidomide Combination Therapy Improves Progression-Free Survival in Elderly Multiple Myeloma Patients: Presented at ASH By Betty S. Riggs NEW ORLEANS -- December 9, 2009 -- In elderly patients newly diagnosed with symptomatic multiple myeloma (MM), lenalidomide in combination with melphalan and prednisone is safe and effective, researchers stated here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition. Antonio Palumbo, MD, Division of Hematology, University of Torino, Torino, Italy, presented the finding here on December 7. In the study, 459 patients aged 65 years and older with newly diagnosed, symptomatic MM were randomised to receive double-blind therapy with melphalan 0.18 mg/kg and prednisone 2 mg/kg plus a placebo or lenalidomide 10 mg/day orally for 9 cycles. The double-blind phase was followed by an open-label extension and follow-up phase. After the double-blind phase, patients in the lenalidomide group received lenalidomide 25 mg/day with or without dexamethasone. All patients received aspirin 100 mg/day as thromboprophylaxis. The primary endpoint was progression-free survival (PFS) and secondary endpoints were overall survival, time-to-progression, response rate, time to response, response duration, time-to-next anti-myeloma therapy, safety, quality of life, and exploratory assessment of cytogenetic abnormalities. At the interim analysis, it was determined by the Data Monitoring Committee that the study had crossed the O’Brien Fleming superiority boundary for the primary endpoint, demonstrating a highly statistically significant improvement in PFS for patients treated with the lenalidomide combination therapy compared with melphalan/prednisone alone. Dr. Palumbo’s presentation included data as of April 2009 with a median follow-up of 9.4 months for PFS. For PFS, there was a 50% risk reduction in the lenalidomide group compared with the melphalan/prednisone-only group (P < .001). The median PFS was reached at 13.0 months in the melphalan/prednisone group, but it was not reached in the lenalidomide combination group. The overall response rate was 67% in the lenalidomide combination group and 49% in the melphalan/prednisone group. With regard to time to first response, 60% of patients in the lenalidomide combination group achieved at least a partial response within the first 3 months, compared with approximately 40% in the melphalan/prednisone group. Median time to first response was 1.9 months in the lenalidomide combination groups and 2.8 months in the melphalan/prednisone group (P < .001). The percentage of discontinuations due to adverse events was 16% in the lenalidomide combination group versus 7% in the melphalan/prednisone group. Grade 3/4 AEs after cycle 9 generally occurred at a higher incidence in the lenalidomide combination group than in the melphalan/prednisone group including anaemia, thrombocytopenia, neutropenia, fatigue, and deep vein thrombosis. According to Dr. Palumbo, lenalidomide plus melphalan and prednisone is a new standard treatment option in elderly patients with newly diagnosed multiple myeloma. Funding for this study was provided by Celgene Corporation. [Presentation title: A Phase III Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Melphalan and Prednisone (MPR) in Elderly Patients With Newly Diagnosed Multiple Myeloma. Abstract 613]
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