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The Role of Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma With Renal Impairment: A Systematic Review

医学 多发性骨髓瘤 临床试验 内科学 入射(几何) 细胞因子释放综合征 肾功能 人口 肿瘤科 血液学 重症监护医学 回顾性队列研究 免疫学 梅德林 抗体 并发症 骨髓 外科 随机对照试验
作者
Ioannis Ntanasis‐Stathopoulos,Sotirios Manganas,Charalampos Filippatos,Konstantinos Karamouzis,Maria Gavriatopoulou,Efstathios Kastritis,Evangelos Terpos,Meletios‐Athanasios Dimopoulos
出处
期刊:American Journal of Hematology [Wiley]
标识
DOI:10.1002/ajh.70312
摘要

Renal impairment (RI), defined as estimated glomerular filtration rate less than 60 mL/min with or without the need for dialysis, is a frequent and severe complication in patients with relapsed/refractory multiple myeloma (RRMM), as it can affect patient prognosis, drug metabolism and treatment options. Although bispecific antibodies (BsAbs) have been approved in RRMM patients, their safety and efficacy in patients with RI remain insufficiently characterized, as most clinical trials excluded individuals with significant renal dysfunction. This systematic review was conducted in accordance with the PRISMA guidelines. PubMed, Scopus, and ScienceDirect were searched up to February 2, 2026, for clinical trials and retrospective real-world studies evaluating BsAbs in RRMM patients with reported data from patients with RI. Abstracts presented in major international scientific congresses over the preceding 3 years, including ASH, IMS, ASCO, EHA, EMN, were also systematically screened. A total of 11 eligible studies were identified, including 3 pivotal trials and 8 real-world cohorts, encompassing 1117 patients. ORR, PFS and OS were comparable between patients with and without RI. Safety profile, including incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity (ICANS), infections and hematologic toxicities were also comparable across renal subgroups. Only the incidence of thrombocytopenia was significantly increased in patients with RI. Overall, BsAbs demonstrate substantial efficacy and manageable safety in RRMM patients with renal dysfunction. Outcomes were similar to those of patients with preserved renal function. These findings support the use of BsAbs in this high-risk population both in clinical practice and in future clinical trials.
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