Sustained improvement in health-related quality of life in transplant-ineligible newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, and dexamethasone: MAIA final analysis of patient-reported outcomes Journal Article
| Authors: | Perrot, A.; Facon, T.; Plesner, T.; Usmani, S. Z.; Kumar, S.; Bahlis, N. J.; Hulin, C.; Orlowski, R. Z.; Nahi, H.; Mollee, P.; Ramasamy, K.; Roussel, M.; Jaccard, A.; Delforge, M.; Karlin, L.; Arnulf, B.; Chari, A.; Wang, G.; Gupta-Werner, N.; Kaila, S.; Pei, H.; Matt, K.; Gries, K. S.; Carson, R.; Borgsten, F.; Weisel, K. |
| Article Title: | Sustained improvement in health-related quality of life in transplant-ineligible newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, and dexamethasone: MAIA final analysis of patient-reported outcomes |
| Abstract: | Objectives: This final post hoc analysis evaluated patient-reported outcomes from the Phase 3 MAIA study of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) after median 64.5-month follow-up in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM), including patient subgroups. Methods: Key scales from the EORTC QLQ-C30 (global health status [GHS], physical functioning, pain, and fatigue) were assessed. Scores were evaluated every 3 months for 1 year, then every 6 months until disease progression. Results: The intent-to-treat population (n = 737) included 46.3% frail, 35.4% 70 to < 75 years old, and 43.6% ≥ 75 years old. D-Rd-treated patients showed improvements from baseline that were sustained over 5 years in the intent-to-treat population and across subgroups by age, frailty, and bone lesions. Greater proportions of patients treated with D-Rd versus Rd achieved minimally important changes for improvement at cycle 36 (year ~3) in GHS (odds ratio, 1.84 [95% CI, 1.16–2.91]), physical functioning (1.93 [1.18–3.14]), pain (1.41 [0.90–2.22]), and fatigue (2.00 [1.24–3.23]). Greater proportions of patients with bone lesions improved with D-Rd versus Rd on GHS and physical functioning. Conclusions: In transplant-ineligible patients with NDMM, D-Rd improved health-related quality of life over a 5-year period versus Rd. Trial Registration: ClinicalTrials.gov: NCT02252172. © 2025 Johnson and Johnson. European Journal of Haematology published by John Wiley & Sons Ltd. |
| Keywords: | controlled study; aged; aged, 80 and over; middle aged; major clinical study; lenalidomide; disease course; fatigue; mortality; treatment duration; follow up; antineoplastic agent; cancer diagnosis; quality of life; multiple cycle treatment; multiple myeloma; pain; randomized controlled trial; antineoplastic combined chemotherapy protocols; dexamethasone; groups by age; monoclonal antibody; bone lesion; antibodies, monoclonal; population research; health status; multicenter study; diagnosis; phase 3 clinical trial; health-related quality of life; patient-reported outcomes; epidemiology; drug therapy; elderly; geriatric patient; physical performance; post hoc analysis; patient-reported outcome; frailty; very elderly; intention to treat analysis; humans; human; male; female; article; daratumumab; european organization for research and treatment of cancer quality of life questionnaire core 30; triplet chemotherapy; doublet chemotherapy; frail |
| Journal Title: | European Journal of Haematology |
| Volume: | 114 |
| Issue: | 5 |
| ISSN: | 0902-4441 |
| Publisher: | John Wiley & Sons |
| Date Published: | 2025-05-01 |
| Start Page: | 883 |
| End Page: | 889 |
| Language: | English |
| DOI: | 10.1111/ejh.14392 |
| PUBMED: | 39952901 |
| PROVIDER: | scopus |
| PMCID: | PMC11976685 |
| DOI/URL: | |
| Notes: | Source: Scopus |
