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MAIA: Long-term results and patient reported outcomes with D-Rd in TI NDMM
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The phase III MAIA trial (NCT02252172) demonstrated that daratumumab plus lenalidomide and dexamethasone (D-Rd) improved PFS (primary endpoint) and OS vs lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with NDMM (N = 737; D-Rd, n = 368; Rd, n = 369). Eligible patients had documented NDMM, an ECOG PS of 0 to 2, and were ineligible for high-dose chemotherapy with ASCT due to age (≥65 years) or comorbidities.1 Facon et al.2 published updated efficacy and safety findings from MAIA (median follow-up, 64.5 months), including a subgroup analysis by patient age (<70 years, ≥70 years to <75 years, ≥75 years, and ≥80 years) in Leukemia. We summarize these findings, along with key findings from a final analysis of PROs published by Perot et al.3 in the European Journal of Hematology. |
| Key learnings |
| PFS was improved with D-Rd vs Rd (median, 61.9 months vs 34.4 months; HR 0.55; 95% CI, 0.45–0.67; p < 0.0001). Median OS was not reached in the D-Rd group vs 65.5 months in the Rd group (HR, 0.66; 95% CI, 0.53–0.83; p = 0.0003).2 |
| The estimated 60-month OS rates were 66.6% with D-Rd vs 53.6% with Rd. D-Rd achieved higher rates of ≥CR (51.1% vs 30.1%), MRD negativity (32.1% vs 11.1%), and sustained MRD negativity (≥18 months, 16.8% vs 3.3%) vs Rd (all p < 0.0001).2 |
| The ITT population consisted of 46.3% frail individuals, 35.4% aged 70 years to <75 years, and 43.6% aged ≥75 years. Patients treated with D-Rd experienced sustained improvements in HRQoL measures from baseline over 5 years, both in the overall ITT population and across subgroups defined by age, frailty, and bone lesions.3 |
| A higher proportion of patients treated with D-Rd vs Rd achieved minimally important changes for improvement at Cycle 36 in GHS, physical functioning, pain, and fatigue. A higher proportion of patients with bone lesions improved with D-Rd vs Rd on GHS and physical functioning.3 |
| These findings continue to support frontline use of D-Rd in transplant-ineligible patients with NDMM. The survival benefit associated with D-Rd is accompanied by long-term consistency or improvements in HRQoL, including in frail and elderly patients.2,3 |
Abbreviations: ASCT autologous stem cell transplant; CI, confidence interval; CR, complete response; D-Rd, daratumumab-lenalidomide-dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; GHS, global health status; HR, hazard ratio; HRQoL, health-related quality of life; ITT, intent-to-treat; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; OR, odds ratio; OS, overall survival; PFS, progression-free survival; PRO, patient-reported outcome; Rd, lenalidomide-dexamethasone.
- Facon T, Kumar S, Plesner T. et al. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(11):1582-1596. DOI: 1016/S1470-2045(21)00466-6
- Facon T, Moreau P, Weisel K. et al. Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes. Leukemia. 2025. Online ahead of print. DOI: 10.1038/s41375-024-02505-2
- Perrot A, Facon T, Plesner T, et al. 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. Eur J Haematol. 2025. Online ahead of print. DOI: 10.1111/ejh.14392
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