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.
Torben PlesnerMeletios- Athanasios DimopoulosAlbert OriolJesús San F MiguelNizar J BahlisNeil RabinKenshi SuzukiSung-Soo YoonDina Ben-YehudaCurly T C M MorrisHartmut GoldschmidtSebastian GrosickiXiang QinJohn FastenauWendy GarvinRobin CarsonThomas RenaudKatharine S GriesPublished in: British journal of haematology (2021)
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.
Keyphrases
- multiple myeloma
- clinical trial
- free survival
- study protocol
- chronic pain
- squamous cell carcinoma
- high dose
- combination therapy
- physical activity
- mental health
- stem cell transplantation
- cross sectional
- phase ii
- pain management
- newly diagnosed
- spinal cord
- hodgkin lymphoma
- open label
- young adults
- anti inflammatory
- chronic lymphocytic leukemia
- data analysis