Quality of Life in Newly Diagnosed Patients with Multiple Myeloma Randomized to Either Krd or Ktd Induction Therapy Followed By Carfilzomib Maintenance or Control (AGMT MM 02 trial)

IntroductionCarfilzomib-based induction therapy is highly effective in newly diagnosed pts with multiple myeloma (NDMM), but information on quality of life (QoL) during first line and maintenance therapy is not available. Here, we analyze patient-reported QoL in transplant-non eligible (TNE) NDMM pts randomized to either KTd or KRd induction therapy followed by second randomization to carfilzomib maintenance, or control.Patients and MethodsAt time of analysis, 101 TNE pts with NDMM had been enrolled, but QoL data documented for ≥ 2 cycles were available in 78 pts so far (median age: 75 years, ISS stage I: 26.6%, II: 35.4%, III: 38.0%, ECOG status 0: 51.9%, 1: 48.1%). Patients were randomized to either 9 cycles KTd or KRd, and subsequently (46 pts with ≥PR) to either carfilzomib maintenance therapy (d1 and 15) or to control for 12 months. Carfilzomib was administered twice weekly (27mg/m2) during cycles 1 and 2, and thereafter weekly at a dose of 56mg/m2. Thalidomide was given daily at 100mg (50mg in pts ≥75 years), lenalidomide at 25mg, d1-21 per 4 week cycle, and dexamethasone at 40 mg (20mg in pts ³75 years) once weekly.QoL was assessed by the QoL questionnaire EORTC QLQ-C30. Assessments were done at baseline, and monthly thereafter for 21 months. A two-sided t-test was used for comparison with the general population. Wilcoxon signed-rank tests were applied to evaluate differences in QoL dimensions within the treatment groups. A clinically meaningful improvement has been defined as a change of ≥10 score points.ResultsComparison with the general population: Mean scores for health-related global QoL (54.1±22.6) and physical functioning (61.2±25.0) were significantly lower in pts compared to those reported for the general population of similar age (67.2±20.6, p