Health‐related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial

Abstract

Summary In the phase 3 POLLUX trial, daratumumab in combination with lenalidomide and dexamethasone (D‐Rd) significantly improved progression‐free survival in patients with relapsed/refractory multiple myeloma (RRMM) compared with lenalidomide and dexamethasone (Rd) alone. Here, we present patient‐reported outcomes (PROs) from POLLUX, assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30‐item (EORTC QLQ‐C30) and the EuroQol 5‐dimensional descriptive system (EQ‐5D‐5L) questionnaires. Changes from baseline are presented as least‐squares mean changes with 95% confidence intervals (CIs) derived from a mixed‐effects model. PRO assessment compliance rates were high and similar in both D‐Rd and Rd groups through cycle 40 (week 156). In this on‐treatment analysis, mean changes from baseline were significantly greater in EORTC QLQ‐C30 global health status, physical functioning, and pain scores in the D‐Rd group versus the Rd group at multiple time points; however, magnitude of changes was low, suggesting no meaningful impact on health‐related quality of life (HRQoL). Subgroup results were similar to those in the overall population. In the POLLUX study, baseline HRQoL was maintained with prolonged D‐Rd treatment. These findings complement the sustained and significant improvement in progression‐free survival observed with D‐Rd and supports its use in patients with RRMM. Clinical trial registration: NCT02076009.

Patient Experience in Clinical Trials: Quality of Life, Financial Burden, and Perception of Care in Patients With Multiple Myeloma or Lymphoma Enrolled on Clinical Trials Compared With Standard Care

“…Most studies report a small initial decline in QoL in the first few months followed by gradual improvement, with QoL often improving to better than patients' baseline. [19][20][21][22] Direct and indirect costs associated with CTs are a major barrier to CT participation. 3,[23][24][25] Patients with lower household income are less likely to participate in CTs.…”

“…$40,000-$65,999 11 (31) 20 (23) $66,000-$105,999 9 (26) 20 (23) $ $106,000 8 ( 23) 24 (27) Choose not to answer/do not know 4 (11) 14 (16) Financial burden at baseline a 5 ( 16) 15 (19) .73…”

Health-related quality of life of multiple myeloma patients after the first-line treatment: results of a prospective cohort study

“…showing benefits for specific chemotherapy regimens (Ludwig et al, 2019;Plesner et al, 2021;Roussel et al, 2020). Our investigation is a longitudinal study conducted in public and private outpatient clinics and analyzed the first-line treatment used in care of MM patients in a Brazilian metropolis.…”

“…Many studies evaluating quality of life of MM patients are cross-sectional studies or clinical trials (Kang & Choi, 2019;Ludwig et al, 2019;Malta et al, 2022;Plesner et al, 2021;Roussel et al, 2020;Stewart et al, 2015); thus, they do not provide information on baseline HRQoL, HRQoL outcomes after chemotherapy treatment, and are not developed in a realworld context. To the best of our knowledge, few longitudinal studies evaluate HRQoL in first-line treatment (Nielsen et al, 2017).…”

Longitudinal Analysis of Patient-Reported Cognitive Function in Multiple Myeloma

“…16 There is no established meaningful clinical difference of the EORTC-CF, but a change of ≥ 10 has been proposed in MM, and across various cancers thresholds for meaningful change range from 4 to 10. [17][18][19][20]…”