Early treatment with lenalidomide and dexamethasone reduced time to progression, in contrast with observation, for patients with high-risk smoldering multiple myeloma, a study published in the journal The Lancet Oncology has shown.1
Observation is the standard of care for patients with smoldering multiple myeloma, an asymptomatic form of myeloma where patients have elevated levels of M protein and plasma cells without the presence of bone disease or anemia. Patients often, however, progress to symptomatic multiple myeloma.
For this multicenter, open-label, phase 3 QuiRedex trial, investigators enrolled 119 adult patients and randomly assigned them 1:1 to receive either early treatment with lenalidomide plus dexamethasone or observation.
At a median follow-up for surviving patients of 75 months, median time to progression was not yet reached (95% CI, 47-not reached) for lenalidomide plus dexamethasone, versus 23 months (95% CI, 16-31) for observation (hazard ratio (HR), 0.24; 95% CI, 0.14-0.41; P < .0001).
Researchers found that progression to multiple myeloma occurred in 39% of patients in the treatment arm, compared with 86% of those in the observation group, though median overall survival from the time of study entry had not been reached in either group (HR, 0.43; 95% CI, 0.21-0.92; P = .024). There was also no significant difference in survival of patients who had received subsequent therapy at the time of progression to symptomatic disease between the 2 arms (HR, 1.34; 95% CI, 0.54-3.30; P = .50).
The most common grade 3 adverse events in patients who received lenalidomide plus dexamethasone were infection (6%), asthenia (6%), neutropenia (5%), and rash (3%).
1. Mateos M-V, Hernandez M-G, Giraldo P, et al. Lenalidomide plus dexamethasone versus observation in patients with high-risk smouldering multiple myeloma (QuiRedex): long-term follow-up a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Jul 8. doi: 10.1016/S1470-2045(16)30124-3 [Epub ahead of print]