Background: Belantamab mafodotin (belamaf) is a BCMA-targeting antibody–drug conjugate used in triple-class refractory multiple myeloma. Despite its efficacy, keratopathy remains a significant dose-limiting toxicity. Following its withdrawal from the U.S. market in 2022, its use in Austria is limited to clinical trials or compassionate use.Methods: In this real-world, retrospective study, we analyzed 36 relapsed/refractory, BCMA-naïve multiple myeloma patients treated at the University Hospital of Vienna (January 2020–June 2024); 42% received a reduced dose (1.9 mg/kg) throughout all treatment cycles. The primary objective was to assess adverse events, particularly keratopathy, and the impact of dose modifications on toxicity and efficacy.Results: The overall response rate was 64%, with responders having significantly fewer prior therapy lines (median 3 vs. 4.5,p= 0.015). Median PFS was 7.3 months, significantly longer in responders (11.1 vs. 1.6 months,p< 0.0001); median OS was 20.1 months, also longer in responders (not reached vs. 18 months,p= 0.031). Keratopathy occurred in 75% of patients; 33% experienced grade 3–4 events. Dose reduction significantly decreased grade 3–4 keratopathy (7% vs. 52%,p= 0.004) and thrombocytopenia (33% vs. 67%,p= 0.048) without compromising efficacy.Conclusions: Belamaf dose reductions improved tolerability without loss of efficacy, supporting reduced dosing in practice.
背景：Belantamab mafodotin（belamaf）是一种靶向BCMA的抗体偶联药物，用于治疗三重难治性多发性骨髓瘤。尽管其疗效显著，角膜病变仍是主要的剂量限制性毒性。该药物于2022年从美国市场撤市后，在奥地利仅限用于临床试验或同情用药。 方法：在这项真实世界回顾性研究中，我们分析了维也纳大学医院（2020年1月至2024年6月）收治的36例复发/难治性、未接受过BCMA靶向治疗的多发性骨髓瘤患者；其中42%的患者在所有治疗周期中均接受了减量剂量（1.9 mg/kg）。主要研究目标是评估不良事件（尤其是角膜病变）以及剂量调整对毒性和疗效的影响。 结果：总体缓解率为64%，缓解者既往治疗线数显著更少（中位数3线 vs. 4.5线，p=0.015）。中位无进展生存期为7.3个月，缓解者显著更长（11.1个月 vs. 1.6个月，p<0.0001）；中位总生存期为20.1个月，缓解者同样更长（未达到 vs. 18个月，p=0.031）。75%的患者发生角膜病变；33%出现3-4级事件。剂量减少显著降低了3-4级角膜病变（7% vs. 52%，p=0.004）和血小板减少症（33% vs. 67%，p=0.048）的发生率，且未影响疗效。 结论：Belamaf剂量减少在保持疗效的同时改善了耐受性，支持在临床实践中采用减量给药方案。
肿瘤(癌症)患者之家