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Continuous Lenalidomide Significantly Improves Outcomes in Elderly Multiple Myeloma Patients
June 13, 2010—During the 15th Congress of the European Hematology Association in Barcelona, Spain, Antonio Palumbo, MD (University of Torino, Italy), presented results from the second interim analysis of a randomized, phase III study in 459 elderly patients with newly diagnosed multiple myeloma, demonstrating a significant reduction in the risk of progression with lenalidomide maintenance following melphalan, prednisone, and lenalidomide induction therapy.
The standard of care for elderly, treatment-naïve patients with multiple myeloma traditionally included melphalan combined with prednisone (MP). The addition of thalidomide, an immunomodulatory agent, to this combination has improved outcomes compared to standard therapy alone. Recently, lenalidomide, a more potent and less toxic derivative of thalidomide, has demonstrated efficacy in patients with multiple myeloma. In a phase I/II study of elderly patients with newly diagnosed multiple myeloma, treatment with the combination of melphalan, prednisone, and lenalidomide (MPR) induction demonstrated an improved overall response rate (ORR), as well as prolonged overall survival (OS) and progression-free survival (PFS) (Palumbo A, et al. Clin Lymphoma Myeloma. 2009;9(2):145-150). The current study compared the following 3 combination regimens in patients (aged ≥65 years) with newly diagnosed multiple myeloma: 1) melphalan (0.18 mg/kg), prednisone (2 mg/kg) and lenalidomide (10 mg/day) induction followed by continuous lenalidomide (MPR-R; n = 152); 2) MPR followed by placebo (MPR; n = 153); and 3) MP plus placebo followed by placebo (MP; n = 154). All patients received nine 28-day cycles of treatment, after which patients on MPR received lenalidomide or placebo and patients on MP received placebo until progression. The primary endpoint was PFS. Key findings from this study are presented below (median follow-up of 21 months):
- MPR-R significantly reduced the risk of disease progression by 58% (P<.001) and improved median PFS (not reached vs 13 months) compared with MP.
It was estimated that 55% of patients receiving MPR-R versus 16% receiving MP would remain progression free after 2 years.
- MPR-R was associated with more hematologic toxicity than MP.
- Grade 3/4 hematologic adverse events
- Neutropenia: 71% vs 30%
- Thrombocytopenia: 39% vs 14%
- Febrile neutropenia: 7% vs 0%
- Grade 3/4 nonhematologic adverse events
- Fatigue: 6% vs 3%
- Deep-vein thrombosis/pulmonary embolism: 4% vs 1%
- Rash: 5% vs 1%
- There were no grade 3/4 events of peripheral neuropathy in either treatment arm
Overall, the MPR-R combination was generally well tolerated and resulted in significantly improved outcomes, suggesting that continuous treatment with lenalidomide is superior to limited duration regimens in elderly patients with newly diagnosed multiple myeloma. Dr Palumbo summarized by noting that continuous lenalidomide therapy has achieved an unprecedented reduction in the risk for progression in patients aged 65 and older.
Haematologica., 2010;95(suppl 1): Abstract 566.
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