Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma |
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| Authors: | M A Dimopoulos A S Swern J S Li M Hussein L Weiss Y Nagarwala R Baz |
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| Institution: | 1.Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece;2.Department of Biostatistics, Celgene Corporation, Summit, NJ, USA;3.Department of Medical Affairs, Celgene Corporation, Summit, NJ, USA;4.Department of Drug Safety, Celgene Corporation, Summit, NJ, USA;5.Department of Hematologic Malignancies, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA |
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| Abstract: | Data from two randomized pivotal, phase 3 trials evaluating the combination of lenalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM) were pooled to characterize the subset of patients who achieved long-term benefit of therapy (progression-free survival ⩾3 years). Patients with long-term benefit of therapy (n=45) had a median duration of treatment of 48.1 months and a response rate of 100%. Humoral improvement (uninvolved immunoglobulin A) was more common in patients with long-term benefit of therapy (79% vs 55% P=0.002). Significant predictors of long-term benefit of therapy in multivariate analysis were age<65 years (P=0.03), β2-microglobulin <2.5 mg/l (P=0.002) and fewer prior therapies (P=0.002). The exposure-adjusted incidence rate (EAIR) of grade 3–4 neutropenia was lower in patients with long-term benefit of therapy (13.9 vs 38.2 per 100 patient-years). The EAIR for invasive second primary malignancy was the same in patients with long-term benefit of therapy and other patients (1.7 per 100 patient-years). These findings indicate that patients with RRMM can experience long-term benefit with lenalidomide and dexamethasone treatment with manageable side effects. |
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