多发性骨髓瘤合并肾功能不全的诊疗进展

Advances in Diagnosis and Treatment of Multiple Myeloma with Renal Insufficiency

摘要: 目的：系统综述新型药物在新诊断(Newly Diagnosed, NDMM)与复发难治(Relapsed/Refractory, RRMM)多发性骨髓瘤合并肾功能不全(Multiple Myeloma with Renal Impairment, MM-RI)患者中的循证证据与肾功能结局，构建结构化的临床实践路径。方法：检索PubMed、Cochrane Library、中国知网(CNKI)等数据库2022年1月至2025年10月文献，纳入≥II期临床试验及真实世界研究，按国际骨髓瘤工作组(International Myeloma Working Group, IMWG) 2023年肾脏缓解标准统一评估终点。结果：共纳入38项研究(n = 4217)。NDMM-RI中，达雷妥尤单抗–硼替佐米–来那度胺–地塞米松(Daratumumab-Bortezomib-Lenalidomide-Dexamethasone, Dara-VRd)方案肾脏完全缓解率达61%；RRMM-RI中，Teclistamab (靶向BCMA-CD3双抗)治疗透析依赖患者总体缓解率(Overall Response Rate, ORR)为93.3%，13.3%实现透析独立。新型药物中74%无需随肾功能调整剂量，≥3级肾毒性发生率 < 1%。结论：以CD38单克隆抗体及双特异性抗体(Bispecific Antibodies, BsAbs)为核心的新型方案能显著改善MM-RI患者的肾功能与生存；建议采用“估算肾小球滤过率(Estimated Glomerular Filtration Rate, eGFR)-微小残留病(Minimal Residual Disease, MRD)-轻链类型”三维度模型进行精准分层与治疗选择，为临床实践提供参考。

Abstract: Objective: To systematically review the evidence and renal outcomes of novel agents in patients with newly diagnosed multiple myeloma with renal impairment (NDMM-RI) and relapsed/refractory multiple myeloma with renal impairment (RRMM-RI), and to establish structured clinical pathways. Methods: A literature search of PubMed, Cochrane Library, and CNKI databases (January 2022 to October 2025) was conducted. Phase ≥II clinical trials and real-world studies were included, with renal endpoints re-classified according to the IMWG 2023 renal response criteria. Results: Thirty-eight studies (n = 4217) were analyzed. In NDMM-RI, the Dara-VRd regimen achieved a renal complete response rate of 61%. In RRMM-RI, Teclistamab yielded an overall response rate (ORR) of 93.3% in dialysis-dependent patients, with 13.3% achieving dialysis independence. No dose adjustment was required for 74% of the novel agents, and the incidence of grade ≥ 3 nephrotoxicity was <1%. Conclusions: Novel regimens centered on CD38 monoclonal antibodies and bispecific antibodies (BsAbs) significantly improve renal response and survival in MM-RI patients. A three-dimensional “eGFR-MRD-light chain” precision stratification model is proposed to guide therapy selection, providing reference for clinical practice.