Introduction : Daratumumab-based combinations are a standard-of-care treatment for relapsed/refractory multiple myeloma (RRMM). Although the combination of daratumumab with lenalidomide and dexamethasone (DRd) has been shown to improve outcomes since 2016, it only became available in Poland through reimbursement in 2023. Objectives : This study aimed to evaluate the real-world efficacy and safety of the DRd regimen in RRMM following its inclusion in the Polish B.54 drug program. Material and methods : We conducted a single-center, retrospective analysis of patients treated with either Rd or DRd between 2017 and 2024. Results : 108 patients were included in the final analysis, 36 patients (33.3%) received DRd and 72 (66.7%) received Rd. DRd was associated with reduced risk of progression or death (HR = 0.39; 95% CI: 0.18–0.83) and overall mortality (HR = 0.29; 95% CI: 0.10–0.81). Hematologic adverse events were more frequent in the DRd group, including grade ≥3 neutropenia ( p = 0.003), anemia ( p = 0.40), and thrombocytopenia ( p = 0.67). Non-hematologic complications, primarily infections, occurred in 39% of DRd and 33% of Rd patients ( p = 0.57). Conclusions : The DRd regimen showed improved efficacy in a real-world Polish RRMM population, with deeper responses and longer survival than Rd. Anemia was more frequent than previously reported, and both groups had shorter OS, likely due to limited access to subsequent lines of therapy. Hematologic toxicity was higher with DRd, but infection rates were similar. These findings emphasize the importance of timely access to innovative treatments through national reimbursement programs.
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Piotrowska et al. (2025) studied this question.
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