Facon T, et al. - Researchers performed final analysis of the FIRST trial to examine survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). They identified significant improvement in survival outcomes with Rd continuous vs MPT treatment. Findings thus supported Rd continuous as a standard of care for patients with transplant-ineligible NDMM.

Methods

• Progression-free survival (PFS; primary comparison: Rd continuous vs MPT) was assessed as the primary endpoint.
• Key secondary endpoint assessed was overall survival (OS) (final analysis prespecified ≥ 60 months’ follow-up).
• Researchers randomized patients to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547).

Results

• With Rd continuous, PFS was significantly longer (HR, 0.69; 96% CI, 0.59-0.79; P < .00001) compared to MPT and was similarly extended compared to Rd18, at a median follow-up of 67 months.
• Researchers observed 10 months longer median OS with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.63-0.95; P=.0144), and similar with Rd18 (62.3 months).
• Rd continuous had a ≈ 30-month-longer median time to next treatment vs Rd18 (69.5 vs 39.9 months) in patients achieving complete or very good partial responses.
• A bortezomib-based therapy was administered to more than half of all patients who received second-line treatment.
• In patients receiving bortezomib after Rd continuous and Rd18 vs after MPT, they observed improved second-line outcomes.
• They observed no new safety concerns, including risk for secondary malignancies.