Publication Date
7-14-2022
Journal
The New England Journal of Medicine
DOI
10.1056/NEJMoa2204925
PMID
35660812
PMCID
PMC10040899
PubMedCentral® Posted Date
3-27-2023
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Keywords
Adult, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Dexamethasone, Disease Progression, Disease-Free Survival, Humans, Lenalidomide, Maintenance Chemotherapy, Melphalan, Multiple Myeloma, Stem Cell Transplantation, Transplantation, Autologous
Abstract
BACKGROUND: In patients with newly diagnosed multiple myeloma, the effect of adding autologous stem-cell transplantation (ASCT) to triplet therapy (lenalidomide, bortezomib, and dexamethasone [RVD]), followed by lenalidomide maintenance therapy until disease progression, is unknown.
METHODS: In this phase 3 trial, adults (18 to 65 years of age) with symptomatic myeloma received one cycle of RVD. We randomly assigned these patients, in a 1:1 ratio, to receive two additional RVD cycles plus stem-cell mobilization, followed by either five additional RVD cycles (the RVD-alone group) or high-dose melphalan plus ASCT followed by two additional RVD cycles (the transplantation group). Both groups received lenalidomide until disease progression, unacceptable side effects, or both. The primary end point was progression-free survival.
RESULTS: Among 357 patients in the RVD-alone group and 365 in the transplantation group, at a median follow-up of 76.0 months, 328 events of disease progression or death occurred; the risk was 53% higher in the RVD-alone group than in the transplantation group (hazard ratio, 1.53; 95% confidence interval [CI], 1.23 to 1.91; P
CONCLUSIONS: Among adults with multiple myeloma, RVD plus ASCT was associated with longer progression-free survival than RVD alone. No overall survival benefit was observed. (Funded by the National Heart, Lung, and Blood Institute and others; DETERMINATION ClinicalTrials.gov number, NCT01208662.).
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