Health-related quality of life (HRQOL) in transplant-ineligible patients (pts) with newly diagnosed multiple myeloma (NDMM): Results from the first trial.

8516^ Background: In the pivotal FIRST trial, continuous lenalidomide plus low-dose dexamethasone (Rd; [N = 535]) improved progression-free survival (PFS) and overall survival (OS) compared with 18 cycles of Rd (Rd 18; [N = 541] for and 12 cycles of melphalan-prednisone-thalidomide (MPT; [N = 547] for 72 weeks) (Facon, Blood 2013). This analysis evaluates HRQOL changes in these NDMM pts. Methods: HRQOL was assessed using the EORTC-QLQ-C30, QLQ-MY20, and EQ-5D validated questionnaires at baseline, end of cycle 1, then 3, 6, 12, 18 months (mos), and at study discontinuation. Cross sectional and longitudinal analyses were performed. Changes from baseline at each time-point were estimated with a focus on seven pre-selected and clinically-relevant domains (Global QOL, Physical Functioning, Pain, Fatigue, Disease Symptoms, Side Effects of Treatment, and Health Utility). Results: Questionnaire compliance was high (≥ 84%) at Cycle 1, 3 and 6 mos across treatment arms. At 12 and 18 mos, the compliance rates were l...