Posted: Friday, February 17, 2023
A randomized phase IV study, conducted by Sara Bringhen, MD, of Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy, and colleagues, aimed to compare the efficacy and safety of two standard regimens—bortezomib and melphalan plus prednisone (VMP) and lenalidomide/dexamethasone (Rd)—in older, transplantation-ineligible patients with multiple myeloma. During the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 751), the study authors suggested that both regimens were equally effective among standard-risk patients, with consistent safety data.
The investigators focused on 231 patients with newly diagnosed multiple myeloma who were ineligible for transplantation because of comorbidities or being 65 years of age or older. Participants were randomly assigned to receive VMP (n = 114) or Rd (n = 117).
Baseline characteristics were similar between both treatment arms. At the median follow-up of 19 months, the median progression-free survival was similar in both groups (29.6 vs. 26.2 months). In comparison, the hazard ratio (HR) increased over time from 0.65 during the first year to 1.37 after the first year of therapy. When stratified by cytogenetic risk, there was a significant effect modification of progression-free survival among the high-risk group (HR = 0.21) versus the standard-risk group (HR = 1.24; P = .036). Of note, age and frailty status did not present as a significant effect modification.
The 2-year overall survival was notably higher among patients treated with VMP (89%) compared with those treated with Rd (75%). With no reported safety concerns, the most frequent grade 3 or 4 adverse events in the VMP arm were thrombocytopenia and neuropathy; adverse events in the Rd arm included neutropenia, infections, and dermatologic toxicities. Furthermore, 66% and 59% of patients in the triplet- and doublet-combination arms experienced at least one dose reduction of any drug.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2022 ASH Annual Meeting and Exposition