Multicenter phase 3 trial of a dexamethasone-sparing regimen with daratumumab and lenalidomide in frail patients with newly diagnosed multiple myeloma

Patients with frailty and newly diagnosed multiple myeloma have worse outcomes than non-frail patients due to higher rates of adverse events and treatment discontinuation. The multicenter phase 3 IFM2017-03 trial evaluated a dexamethasone-sparing regimen for frail patients with NDMM. Patients with NDMM and a frailty score of 2 or more were randomized to daratumumab and lenalidomide, with dexamethasone limited to the first two cycles (dexamethasone-sparing group) or lenalidomide and dexamethasone (control group). Median progression-free survival and overall survival were longer in the dexamethasone-sparing group compared to the control group, with no additional safety concerns.