Daratumumab plus lenalidomide/dexamethasone in untreated multiple myeloma: Analysis of key subgroups of the MAIA study Journal Article
| Authors: | Moreau, P.; Facon, T.; Usmani, S. Z.; Bahlis, N.; Raje, N.; Plesner, T.; Orlowski, R. Z.; Basu, S.; Nahi, H.; Hulin, C.; Quach, H.; Goldschmidt, H.; O’Dwyer, M.; Perrot, A.; Venner, C. P.; Weisel, K.; Tiab, M.; Macro, M.; Frenzel, L.; Leleu, X.; Wang, G.; Pei, H.; Krevvata, M.; Carson, R.; Borgsten, F.; Kumar, S. K. |
| Article Title: | Daratumumab plus lenalidomide/dexamethasone in untreated multiple myeloma: Analysis of key subgroups of the MAIA study |
| Abstract: | In the MAIA study (median follow-up, 56.2 months), daratumumab plus lenalidomide and dexamethasone (D-Rd) significantly improved progression-free survival (PFS) and overall survival versus lenalidomide and dexamethasone (Rd) alone in transplant-ineligible newly diagnosed multiple myeloma (NDMM). In this post hoc analysis of clinically important subgroups in MAIA (median follow-up, 64.5 months), transplant-ineligible patients with NDMM were randomized 1:1 to D-Rd or Rd. The primary endpoint was PFS; secondary endpoints included overall response rate (ORR) and measurable residual disease (MRD)–negativity rate (10–5). PFS favored D-Rd versus Rd in most subgroups, including patients aged ≥75 years (HR, 0.59; 95% CI, 0.44–0.79), frail patients (HR, 0.64; 95% CI, 0.48–0.85), patients with high-risk cytogenetics (HR, 0.59; 95% CI, 0.44–0.80), and patients with isolated gain(1q21) (HR, 0.36; 95% CI, 0.19–0.67). ORRs, MRD-negativity rates, and sustained (≥12 months) MRD-negativity rates were higher with D-Rd versus Rd across subgroups. In patients aged ≥75 years, rates of grade 3/4 and serious treatment-emergent adverse events (TEAEs) were similar for D-Rd and Rd, but discontinuation due to TEAEs was lower for D-Rd. Results support use of D-Rd for high-risk patients, supporting D-Rd as a standard of care for transplant-ineligible NDMM. This trial was registered at www.clinicaltrials.gov as NCT02252172. (Figure presented.) © The Author(s), under exclusive licence to Springer Nature Limited 2025. |
| Keywords: | adult; controlled study; aged; aged, 80 and over; middle aged; survival rate; unclassified drug; major clinical study; overall survival; lenalidomide; clinical trial; fatigue; mortality; neutropenia; diarrhea; drug efficacy; drug safety; hypertension; outcome assessment; follow up; follow-up studies; antineoplastic agent; progression free survival; multiple cycle treatment; multiple myeloma; anemia; leukopenia; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; dexamethasone; bone pain; pathology; high risk patient; monoclonal antibody; asthenia; hyperglycemia; lymphocytopenia; pneumonia; lung embolism; acute kidney failure; hypokalemia; hyponatremia; antibodies, monoclonal; fluorescence in situ hybridization; minimal residual disease; neoplasm, residual; multicenter study; cataract; open study; lactate dehydrogenase; phase 3 clinical trial; beta 2 microglobulin; drug therapy; autosome; karyotyping; atrial fibrillation; disease exacerbation; chronic kidney failure; cytogenetic analysis; creatinine clearance; post hoc analysis; adverse event; lenalidomide plus dexamethasone; overall response rate; high throughput sequencing; gammopathy; charlson comorbidity index; very elderly; intention to treat analysis; humans; human; male; female; article; daratumumab; ecog performance status; bone marrow aspiration; chromosome 1q21 |
| Journal Title: | Leukemia |
| Volume: | 39 |
| Issue: | 3 |
| ISSN: | 0887-6924 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2025-03-01 |
| Start Page: | 710 |
| End Page: | 719 |
| Language: | English |
| DOI: | 10.1038/s41375-024-02506-1 |
| PUBMED: | 39815052 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
