Dose/schedule-adjusted Rd-R vs continuous Rd for elderly, intermediate-fit patients with newly diagnosed multiple myeloma
Alessandra Larocca, Francesca Bonello, Gianluca Gaidano, Mattia D'Agostino, Massimo Offidani, Nicola Cascavilla, Andrea Capra, Giulia Benevolo, Patrizia Tosi, Monica Galli, Roberto Marasca, Nicola Giuliani, Annalisa Bernardini, Elisabetta Antonioli, Delia Rota-Scalabrini, Claudia Cellini, Alessandra Pompa, Federico Monaco, Francesca Patriarca, Tommaso Caravita di Toritto, Paolo Corradini, Paola Tacchetti, Mario Boccadoro, Sara Bringhen, Alessandra Larocca, Francesca Bonello, Gianluca Gaidano, Mattia D'Agostino, Massimo Offidani, Nicola Cascavilla, Andrea Capra, Giulia Benevolo, Patrizia Tosi, Monica Galli, Roberto Marasca, Nicola Giuliani, Annalisa Bernardini, Elisabetta Antonioli, Delia Rota-Scalabrini, Claudia Cellini, Alessandra Pompa, Federico Monaco, Francesca Patriarca, Tommaso Caravita di Toritto, Paolo Corradini, Paola Tacchetti, Mario Boccadoro, Sara Bringhen
Abstract
Lenalidomide-dexamethasone (Rd) is standard treatment for elderly patients with multiple myeloma (MM). In this randomized phase 3 study, we investigated efficacy and feasibility of dose/schedule-adjusted Rd followed by maintenance at 10 mg per day without dexamethasone (Rd-R) vs continuous Rd in elderly, intermediate-fit newly diagnosed patients with MM. Primary end point was event-free survival (EFS), defined as progression/death from any cause, lenalidomide discontinuation, or hematologic grade 4 or nonhematologic grade 3 to 4 adverse event (AE). Of 199 evaluable patients, 101 received Rd-R and 98 continuous Rd. Median follow-up was 37 months. EFS was 10.4 vs 6.9 months (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.95; P = .02); median progression-free survival, 20.2 vs 18.3 months (HR, 0.78; 95% CI, 0.55-1.10; P = .16); and 3-year overall survival, 74% vs 63% (HR, 0.62; 95% CI, 0.37-1.03; P = .06) with Rd-R vs Rd, respectively. Rate of ≥1 nonhematologic grade ≥3 AE was 33% vs 43% (P = .14) in Rd-R vs Rd groups, with neutropenia (21% vs 18%), infections (10% vs 12%), and skin disorders (7% vs 3%) the most frequent; constitutional and central nervous system AEs mainly related to dexamethasone were more frequent with Rd. Lenalidomide was discontinued for AEs in 24% vs 30% and reduced in 45% vs 62% of patients receiving Rd-R vs Rd, respectively. In intermediate-fit patients, switching to reduced-dose lenalidomide maintenance without dexamethasone after 9 Rd cycles was feasible, with similar outcomes to standard continuous Rd. This trial was registered at www.clinicaltrials.gov as #NCT02215980.
© 2021 by The American Society of Hematology.
Source: PubMed