Lenalidomide, Bortezomib, and Dexamethasone with Transplantation in Myeloma.
By M. Attal, V. Lauwers-Cances, C. Hulin, X. Leleu, D. Caillot, M. Escoffre, B. Arnulf, M. Macro, K. Belhadj, L. Garderet and 16 more. New England Journal of Medicine, 2017
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Background High‐dose chemotherapy plus autologous stem‐cell transplantation has been the standard treatment for newly diagnosed multiple myeloma in adults up to 65 years of age. However, promising data on the use of combination therapy with lenalidomide, bortezomib, and dexamethasone (RVD) in this population have raised questions about the role and timing of transplantation. Methods We randomly assigned 700 patients with multiple myeloma to receive induction therapy with three cycles of RVD and then consolidation therapy with either five additional cycles of RVD (350 patients) or high‐dose melphalan plus stem‐cell transplantation followed by two additional cycles of RVD (350 patients). Patients in both groups received maintenance therapy with lenalidomide for 1 year. The primary end point was progression‐free survival. Results Median progression‐free survival was significantly longer in the group that underwent transplantation than in the group that received RVD alone (50 months vs. 36 months; adjusted hazard ratio for disease progression or death, 0.65; P<0.001). This benefit was observed across all patient subgroups, including those stratified according to International Staging System stage and cytogenetic risk. The percentage of patients with a complete response was higher in the transplantation group than in the RVD‐alone group (59% vs. 48%, P=0.03), as was the percentage of patients in whom minimal residual disease was not detected (79% vs. 65%, P<0.001). Overall survival at 4 years did not differ significantly between the transplantation group and the RVD‐alone group (81% and 82%, respectively). The rate of grade 3 or 4 neutropenia was significantly higher in the transplantation group than in the RVD‐alone group (92% vs. 47%), as were the rates of grade 3 or 4 gastrointestinal disorders (28% vs. 7%) and infections (20% vs. 9%). No significant between‐group differences were observed in the rates of treatment‐related deaths, second primary cancers, thromboembolic events, and peripheral neuropathy. Conclusions Among adults with multiple myeloma, RVD therapy plus transplantation was associated with significantly longer progression‐free survival than RVD therapy alone, but overall survival did not differ significantly between the two approaches. (Supported by Celgene and others; IFM 2009 Study ClinicalTrials.gov number, NCT01191060.)
Subfields: Hematology, Oncology
View Paper: https://www.semanticscholar.org/paper/ca33f8e918b8f2db1c5d2884eb02b3a862664dc6
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Citations in the corpus
- Multiple myeloma: 2022 update on diagnosis, risk stratification, and management (2022, methodology): “pared early versus delayed ASCT in patients treated with VRd followed by lenalidomide maintenance.(43) Patients were randomized to receive either VRd (3 cycles) followed by ASCT and then VRd consolidation”
- Multiple myeloma: 2020 update on diagnosis, risk‐stratification and management (2020, methodology): “The data to support their use from recent randomized trials using new active agents for multiple myeloma are provided in Table 7.(38,39,88,89) In order to initiate therapy, patients must meet criteria for multiple myeloma as outlined in Table 1.”