Abstract
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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | British Journal of Haematology |
| Vol/bind | 194 |
| Udgave nummer | 1 |
| Sider (fra-til) | 132-139 |
| ISSN | 0007-1048 |
| DOI | |
| Status | Udgivet - jul. 2021 |
Bibliografisk note
Funding Information:The authors thank the patients who participated in this study and their families, the staff members at the study sites, the data and safety monitoring committee, and the staff members involved in data collection and analysis. The POLLUX study was funded by Janssen Research & Development, LLC. Editorial and medical writing support was provided by Corey Eagan, MPH, of Eloquent Scientific Solutions, and was funded by Janssen Global Services, LLC.
Funding Information:
TP served in a consulting or advisory role for AbbVie, Celgene, Genmab, Janssen, and Takeda; received research funding from Janssen; participated in a speakers' bureau for Janssen; and received travel, accommodations, and expenses from Celgene. MD received honoraria from Amgen, Bristol‐Myers Squibb, Celgene, Janssen‐Cilag, and Takeda; and served in a consulting or advisory role for Amgen, Bristol‐Myers Squibb, Celgene, Janssen‐Cilag, and Takeda. AO served in a consulting or advisory role for Amgen, Celgene, and Janssen; and participated in a speakers' bureau for Amgen and Celgene. JSM served in a consulting or advisory role for AbbVie, Amgen, Bristol‐Myers Squibb, Celgene, Janssen, MSD, Novartis, Roche, Sanofi, and Takeda. NB received honoraria from Amgen, Celgene, Janssen, and Takeda; served in a consulting or advisory role for Amgen, Celgene, Janssen, and Takeda; participated in a speakers' bureau for Amgen, Celgene, and Janssen; received research funding from Celgene and Janssen; provided expert testimony for Celgene and Janssen; and received travel, accommodations, and expenses from Amgen, Celgene, Janssen, and Takeda. NR served in a consulting or advisory role for Amgen, Celgene, Karyopharm, Janssen, Novartis, and Takeda; participated in a speakers' bureau for Celgene, Janssen, and Takeda; and received travel, accommodations, and expenses from Celgene, Janssen, and Takeda. KS received honoraria from Celgene, Janssen, and Takeda; and served in a consulting or advisory role for Takeda. SSY served in a consulting or advisory role for Amgen, Astellas Celgene, Janssen, Novartis, and Takeda; received honoraria from Novartis; received research funding from Kyowa Kirin, Novartis, and Yuhan Pharmaceutical. GC received honoraria from Celgene, Janssen‐Cilag, Karyopharm Therapeutics, and Takeda; participated in a speakers' bureau for Amgen, Janssen‐ Cilag, Jazz Pharmaceuticals, and Takeda; received research funding from Celgene and Takeda; and received travel, accommodations, and expenses from Takeda. HG served in a consulting or advisory role for Adaptive Biotechnologies, Amgen, Bristol‐Myers Squibb, Celgene, Janssen‐Cilag, Sanofi, and Takeda; received honoraria from Art tempi, Bristol‐Myers Squibb, Celgene, Chugai Pharma, Janssen‐Cilag, Novartis, and Sanofi; received research funding from Amgen, Bristol‐Myers Squibb, Celgene, Chugai Pharma Europe, Janssen, Molecular Partners, MSD, Sanofi, Takeda, and Novartis; and received travel, accommodations, and expenses from Adaptive Biotechnologies, Amgen, Bristol‐Myers Squibb, Celgene, Janssen‐Cilag, Novartis, Sanofi, and Takeda. TA is an employee of Genmab. XQ, JF, WG, RK, TR, and KG are employees of Janssen. DB‐Y and SG have no conflicts of interest to disclose.
Publisher Copyright:
© 2021 British Society for Haematology and John Wiley & Sons Ltd