Multicenter phase 2 trial of frontline RVD-lite in transplant-ineligible multiple myeloma: final results

A multicenter phase 2 trial in the USA evaluated modified-intensity lenalidomide, bortezomib, and dexamethasone (RVD-lite) as frontline treatment for transplant-ineligible multiple myeloma (MM). Final results of the trial have now been published. Fifty patients were enrolled, median age was 73 years (range 65-91), and 14% had an ECOG performance status of 2. Thirty-three patients (66%) received lenalidomide maintenance. At best response, objective response rate was 90% and very good partial response rate was 66%. At a median follow-up of 72 months, the median progression-free survival was 42 months with a 5-year PFS rate of 40%) and the median overall survival was 76 months with a 5-year OS rate of 63%. ECOG performance status of 2 was associated with inferior PFS and OS. Two-patients (4%) discontinued treatment due to toxicity; there was no treatment-related mortality. The authors conclude that RVD-lite is a well-tolerated and highly effective regimen in transplant-ineligible MM. This study provides the framework for frailty-adapted triplet and quadruplet regimens in MM patients.