Health related quality of life (HRQoL) outcomes from the phase III CANDOR study comparing carfilzomib, dexamethasone, and daratumumab (KdD) to carfilzomib and dexamethasone (Kd) in patients (Pts) with relapsed or refractory multiple myeloma.

Abstract

e20563 Background: In the CANDOR study (N = 466) of pts with relapsed or refractory multiple myeloma (RRMM), a statistically significant improvement in progression-free survival (HR = 0.63; 95% CI, 0.46-0.85; p = 0.0014) was observed in the KdD vs Kd arms. Here, we report a secondary endpoint of CANDOR evaluating HRQoL. Methods: HRQoL was assessed using the Global Health status (GHS)/Quality of Life (QoL) domain of the European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30), which was completed on Day 1 of Cycle 1 and every 28±7 days through the first follow-up visit. The GHS/QoL was scored from 0–100, with higher scores indicating better QoL. The scores were compared between the KdD and Kd arms using a restricted maximum likelihood-based mixed effects model for repeated measures under the assumption of missing data at random. A minimally important difference of 5 points between arms was prespecified. An exploratory time-by-time sensitivity analysis by ANCOVA was used to evaluate the treatment effect on the GHS/QoL score among pts who remained on treatment until the specified visit (cycle 3 and every 3 cycles thereafter). Results: GHS/QoL completion rates from baseline through up to cycle 26 (study ongoing) for randomized pts who remained on treatment were > 81% for both the KdD and Kd arms; the median extent of missing GHS/QoL data was 5.3% for the KdD arm and 12.1% for the Kd arm. KdD was associated with higher GHS/QoL scores relative to Kd starting at Cycle 7 and this was maintained until Cycle 26 (by mixed effect model, overall LSME difference [95% CI], 0.06 [–2.39, 2.50]; p = 0.96). At Cycle 18, the mean difference between arms approached the prespecified clinically meaningful difference of 5 points (by ANCOVA, [difference: KdD–Kd (SE), 4.06 (2.45)]). In an exploratory analysis of pts who remained on treatment at each cycle, a higher rate of pts reported an improvement of ≥10 points in GHS/QoL score from baseline in the KdD vs Kd arms, with the greatest differences observed at Cycle 7 (Odds Ratio [OR] for KdD/Kd [95% CI], 2.37 [1.29, 4.34]), Cycle 9 (OR [95% CI], 2.96 [1.46–6.03]), Cycle 13 (OR [95% CI], 2.44 (1.15-5.17), and Cycle 16 (OR [95% CI], 2.77 [1.27–6.07]). Conclusions: In addition to the superior clinical benefit observed with KdD vs Kd, HRQoL was maintained with the KdD triplet. A higher rate of pts treated with KdD reported an improvement of ≥10 points from baseline. Clinical trial information: NCT03158688.