Abstract
Background. Data from real-life clinical practice studies provide additional information on the efficacy of new antitumor therapy regimens, including in patients who meet exclusion criteria for clinical trials.Aim. To evaluate the Isaomex triplet efficacy in multiple myeloma patients in real clinical practice.Materials and methods. From 2021 to 2024, the retrospective study included 83 double refractory multiple myeloma patients from 26 centers aged 38 to 85 years (median 63), who received the Isaomex triplet. Glomerular filtration rate ˂ 60 mL/min was detected at the time of isatuximabbased triplet initiation in 18 % patients, 2 of whom were on program hemodialysis. The median of previous therapy lines was 2 (1–6). The median time from diagnosis to initiation of isatuximabbased triplet therapy was 47 months (5–203). Survival curves were constructed using the Kaplan–Meier method. Statistical analysis was performed using Statistica 10 program.Results. Isaomex triplet therapy resulted in overall and renal responses in 76 % and 61 % of cases, respectively. The median progression free survival was 13.5 months. In the group of patients who did not receive daratumumab at previous stages, the median progression free survival was significantly higher and was 28 months vs 8 months (p ˂ 0.05). Threeyear overall survival was 81 %. Discontinuation of isatuximab due to the development of adverse event was recorded in 2 cases (2 %). In the group of patients with bone plasmacytomas (n = 46), Isaomex therapy resulted in an overall response rate of 67 %; 12‑month progression free survival was 48 %, and 1‑year overall survival was 76 %.Conclusion. The results of the Isaomex triplet use in real clinical practice for the treatment of relapsed multiple myeloma showed data comparable to the ICARIA registration study on the frequency of achieving a response, duration of progression free survival and overall survival. The triplet efficiency was shown in comorbid patients, with advanced stages and those undergoing renal replacement therapy.
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