Randomized phase III trial of consolidation therapy with bortezomib–lenalidomide–Dexamethasone (VRd) vs bortezomib–dexamethasone (Vd) for patients with multiple myeloma who have completed a dexamethasone based induction regimen

Long-awaited results from the the Southwest Oncology Group (SWOG) trial comparing bortezomib–lenalidomide-dexamethasone (VRd) versus lenalidomide-dexamethasone (Rd) as induction treatment for previously untreated multiple myeloma (MM) patients were recently presented (S0777).1 Results justified the early adoption of VRd in the frontline setting over 5 years ago by the NCCN based on Level 2A evidence according to their guidelines.2 The randomized study E1A05 also sought to evaluate VRd superiority over a doublet (Vd), but in the consolidation setting. The trial was closed to enrollment prematurely due to slow accrual. Results reported here include 48 enrolled patients.This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L Comis, MD, and Mitchell D Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under award numbers: CA180820, CA180794, CA21115, CA23318, CA66636, CA180790, CA13650, CA189956, CA35412, CA15488, CA180799 and CA21076.http://www.sherpa.ac.uk/romeo/issn/2044-5385/am2016Medical Oncolog

Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma

This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2-microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end-point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; P = 0.026) and progression-free survival (14.1 vs. 9.5 months, P = 0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, P = 0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, P = 0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, P = 0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second-line MM therapy and the data suggest that the greatest benefit occurs with earlier use. © 2009 Blackwell Munksgaard