Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes: MULTIPLE MYELOMA, GAMMOPATHIES Journal Article
| Authors: | Facon, T.; Moreau, P.; Weisel, K.; Goldschmidt, H.; Usmani, S. Z.; Chari, A.; Plesner, T.; Orlowski, R. Z.; Bahlis, N.; Basu, S.; Hulin, C.; Quach, H.; O’Dwyer, M.; Perrot, A.; Jacquet, C.; Venner, C. P.; Raje, N.; Tiab, M.; Macro, M.; Frenzel, L.; Leleu, X.; Cook, G.; Wang, G.; Pei, H.; Krevvata, M.; Carson, R.; Borgsten, F.; Kumar, S. K. |
| Article Title: | Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes: MULTIPLE MYELOMA, GAMMOPATHIES |
| Abstract: | In the MAIA study, daratumumab plus lenalidomide and dexamethasone (D-Rd) improved progression-free survival (PFS) and overall survival (OS) versus lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). We report updated efficacy and safety from MAIA (median follow-up, 64.5 months), including a subgroup analysis by patient age (<70, ≥70 to <75, ≥75, and ≥80 years). Overall, 737 transplant-ineligible patients with NDMM were randomized 1:1 to D-Rd or Rd. The primary endpoint, PFS, was improved with D-Rd versus Rd (median, 61.9 vs 34.4 months; hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.45–0.67; P < 0.0001). Median OS was not reached in the D-Rd group versus 65.5 months in the Rd group (HR, 0.66; 95% CI, 0.53–0.83; P = 0.0003); estimated 60-month OS rates were 66.6% and 53.6%, respectively. D-Rd achieved higher rates of complete response or better (≥CR; 51.1% vs 30.1%), minimal residual disease (MRD) negativity (32.1% vs 11.1%), and sustained MRD negativity (≥18 months: 16.8% vs 3.3%) versus Rd (all P < 0.0001). D-Rd demonstrated clinically meaningful efficacy benefits across age groups. No new safety concerns were observed. Updated results (median follow-up, >5 years) continue to support frontline use of D-Rd in transplant-ineligible patients with NDMM. © The Author(s) 2024. |
| Keywords: | adult; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; major clinical study; overall survival; lenalidomide; clinical trial; mortality; outcome assessment; follow up; follow-up studies; antineoplastic agent; progression free survival; multiple myeloma; randomized controlled trial; antineoplastic combined chemotherapy protocols; cohort analysis; dexamethasone; pathology; transplantation; monoclonal antibody; confidence interval; antibodies, monoclonal; minimal residual disease; multicenter study; diagnosis; long term care; open study; hazard ratio; phase 3 clinical trial; drug therapy; fisher exact test; myeloma; overall response rate; very elderly; humans; prognosis; human; male; female; article; daratumumab |
| Journal Title: | Leukemia |
| Volume: | 39 |
| Issue: | 4 |
| ISSN: | 0887-6924 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2025-04-01 |
| Start Page: | 942 |
| End Page: | 950 |
| Language: | English |
| DOI: | 10.1038/s41375-024-02505-2 |
| PUBMED: | 40016302 |
| PROVIDER: | scopus |
| PMCID: | PMC11976258 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
