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Background and Importance Daratumumab in combination with lenalidomide-dexamethasone (DR-d) is considered one of the recommended regimens for transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM).Aim and Objectives This study aimed to evaluate the real-world effectiveness of DRd for TIE patients with NDMM, compared with a historical cohort treated with Rd (lenalidomide, dexamethasone).Material and Methods We conducted a retrospective, observational study at a tertiary hospital. We included TIE patients with NDMM who initiated DR-d or Rd between January 2019 and October 2024. Clinical data were extracted from electronic health records and the onco-haematology software Farmis-Oncofarm. Effectiveness was assessed by the 24-month progression-free survival (PFS) rate, and by the percentage of patients with complete response (CR) and very good partial response (VGPR).Results A total of 65 patients were analysed: 41 received DR-d and 24 received Rd. Demographic and clinical characteristics of the two groups were well balanced at baseline, as shown in the following table. DR-d (N=41) Rd (N=24) Median age (range)---yr 78(53-88) 81(65-87) Age category –no.(%) <65yr 2(5) 1(4) 65-70yr 3(7) 2(8) 70-75yr 8(20) 2(8) ≥75yr 28(68) 19(80) ISS disease stage --- no.(%) I 12(30) 7(29) II 11(27) 7(29) III 17(41) 9(38) Unknown 1(2) 1(4) At a median follow-up of 15.6 months, disease progression or death had occurred in 26 patients (7/41(17%) in the DRd group versus 19/24(79.2%) in the Rd group). The Kaplan–Meier estimate of the percentage of patients who were alive without disease progression at 24 months was 72.1% (95% confidence interval (CI),54.1–96.2) in the DR-d group and 45.8% (95% CI 29.7–70.8) in the Rd group. The hazard ratio for disease progression or death in the daratumumab group as compared with the control group was 0.32 (95% CI,0.13-0.79,P=0.014).The percentage of patients with a CR or better was significantly higher in DR-d group than in Rd group (36% vs 12.5%), as was the percentage with VGPR or better (85% vs 59%)Conclusion and Relevance In real-world practice, TIE patients with NDMM treated with DR-d showed significantly lower risk of progression or death compared with those receiving Rd. The DRd combination significantly increases the CR and VGPR compared to the Rd regimen.Conflict of Interest No conflict of interest