Among older patients with newly diagnosed multiple myeloma, treatment with Revlimid® (lenalidomide) in combination with melphalan and prednisone, followed by Revlimid maintenance therapy (MPR-R) may result in better progression-free survival than two other treatment combinations. These interim results from an ongoing Phase III clinical trial were presented at the 52nd annual meeting of the American Society of Hematology.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.
Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy.
To evaluate Revlimid in the initial treatment of multiple myeloma, researchers are conducting a Phase III clinical trial among 459 patients who are 65 years of age or older and not eligible for a stem cell transplant. Patients were assigned to one of three treatment groups:
1) Revlimid in combination with melphalan and prednisone, followed by Revlimid alone (MPR-R).
2) Revlimid in combination with melphalan and prednisone, followed by placebo (MPR).
3) Placebo, melphalan, and prednisone, followed by placebo (MP)
The results indicated that continuous Revlimid (MPR-R) produced better outcomes than either MPR or MP:
- Overall response rate was 77% among patients treated with MPR-R and 50% among patients treated with MP.
- Progression-free survival was 31 months among patients treated with MPR-R compared with 13 months among patients treated with MP. Patients treated with MPR-R also had significantly better progression-free survival than patients treated with MPR.
- Additional follow-up will be necessary before overall survival results are available.
- Patients treated with MPR-R were more likely than patients treated with MP to experience serious (grade 3 or 4) neutropenia (low white blood cell count), thrombocytopenia (low platelet count), and anemia (low red blood cell count).
These results suggest that among older, transplant-ineligible patients, treatment of newly diagnosed multiple myeloma with continuous Revlimid may delay the progression of myeloma. This study is ongoing; final results will be presented when follow-up is complete.
Reference: Palumbo A, Delforge M, Catalano J et al. A phase 3 study evaluating the efficacy of lenalidomide combined with melphalan and prednisone in patients ?65 years with newly diagnosed multiple myeloma (NDMM): continuous use of lenalidomide vs fixed-duration regimens. Presented at the 52nd annual meeting of the American Society of Hematology. Orlando, FL, December 4-7, 2010. Abstract 622.
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