CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Elranatamab for Relapsed/Refractory Multiple Myeloma With Severe Renal Impairment Requiring Hemodialysis.
Elranatamab for Relapsed/Refractory Multiple Myeloma With Severe Renal Impairment Requiring Hemodialysis.
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伴有透析依赖性肾功能损害的复发/难治性多发性骨髓瘤（RRMM）患者因被排除在临床试验之外、缺乏循证指南以及预后较差，治疗选择有限。靶向B细胞成熟抗原（BCMA）的双特异性抗体在RRMM治疗中显示出前景，但在这一脆弱人群中仍缺乏充分研究。为说明这一问题，我们介绍一例68岁女性患者，患三药暴露RRMM及需血液透析的终末期肾病，在daratumumab、bortezomib、lenalidomide和dexamethasone治疗后进展，接受elranatamab作为二线治疗。尽管在初始给药期间出现I级细胞因子释放综合征，但症状经tocilizumab和dexamethasone有效管理，得以继续治疗。患者在7周内达到非常好的部分缓解。尽管透析依赖持续存在，但治疗耐受良好，不良事件可控。
根据文献，BCMA导向的免疫疗法，包括teclistamab、belantamab mafodotin和idecabtagene vicleucel，已在透析依赖性RRMM患者中显示出疗效，但数据仍然有限。药代动力学分析表明，轻度或中度肾功能损害对elranatamab的药代动力学没有显著影响。尽管尚无回顾性研究或病例系列探讨elranatamab在透析依赖性患者中的使用，但一份单例病例报告提示，尽管缺乏全面的药代动力学数据，其在该人群中的给药既可行且耐受良好。本综述强调了elranatamab在管理透析依赖型RRMM患者中的可行性、安全性和令人鼓舞的疗效，这是文献中的第二例病例报告。通过为双特异性抗体在终末期肾病患者中的应用提供真实世界证据，本综述强调了为这一脆弱人群扩大治疗选择的可能性，同时强调需要对感染的预防和管理进行警惕性监测。需要前瞻性研究来验证这些发现，并优化RRMM合并严重肾功能损害患者的治疗策略。
Relapsed/refractory multiple myeloma (RRMM) patients with dialysis-dependent renal impairment face limited therapeutic options due to exclusion from clinical trials, a lack of evidence-based guidelines, and inferior outcomes. Bispecific antibodies targeting B-cell maturation antigen (BCMA) have shown promise in RRMM treatment but remain understudied in this vulnerable population. To illustrate this issue, we introduce the case of a 68-year-old female with triple-class RRMM and end-stage renal disease requiring hemodialysis, treated with elranatamab as a second line treatment following progression after therapy with daratumumab, bortezomib, lenalidomide, and dexamethasone. Despite experiencing grade I cytokine release syndrome during the initial administrations, symptoms were managed effectively with tocilizumab and dexamethasone, allowing treatment continuation. The patient achieved a very good partial remission within 7 weeks. Although hemodialysis dependence persisted, the therapy was well-tolerated with manageable adverse events. According to the literature, BCMA-directed immunotherapies, including teclistamab, belantamab mafodotin, and idecabtagene vicleucel, have shown efficacy in dialysis-dependent RRMM patients, though data remain limited.
Pharmacokinetic analyses indicate that mild or moderate renal impairment does not have a significant impact on the pharmacokinetics of elranatamab. Although no retrospective studies or case series have investigated the use of elranatamab in dialysis-dependent patients, a single case report suggests that its administration is both feasible and well-tolerated in this population despite the absence of comprehensive pharmacokinetic data. This review highlights feasibility, safety, and encouraging efficacy of elranatamab in managing RRMM in a dialysis-dependent patient, representing the second case report in the literature.
By providing real-world evidence for the use of bispecific antibodies in end stage renal disease patients, this review emphasizes the potential for expanding therapeutic options to this vulnerable population while highlighting the need for vigilant monitoring of infection prevention and management. Prospective studies are warranted to validate these findings and optimize therapeutic strategies for patients with RRMM and severe renal impairment.
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