Abstract: Background　Multiple myeloma will relapse in the majority of such patients as there is no cure for it.Daratumumab，a CD38 human monoclonal antibody，has been reported by foreign studies to have significant clinical activity in relapsed or refractory multiple myeloma.However，there are limited data on its efficacy and toxicity profiles in Chinese patients.Objective　To investigate the clinical efficacy and safety of daratumumab in the treatment of patients with relapsed or refractory multiple myeloma.Methods　From October 2019 to June 2020，9 patients with relapsed or refractory multiple myeloma treated with daratumumab-based chemotherapy were selected from Department of Hematology，Beijing Jishuitan Hospital.Their clinical data，follow-up response and adverse reactions to daratumumab-based regimens were retrospectively analyzed.Results　Among the 9 patients，7 were available for response evaluation.Two（28.6%） achieved complete response，two（28.6%）achieved very good partial response，one（14.3%）achieved partial response，one（14.3%）achieved minimal response and one （14.3%） achieved stable disease.The overall response rate was 71.4%（5/7）.The most common hematological adverse events were thrombocytopenia，neutropenia and lymphopenia，with the incidences of grade 3 and 4 of 33.3%（3/9）and 33.3%（3/9）and 55.6%（5/9），respectively.The percentage of infusion related reactions of daratumumab was 44.4%（4/9）.Conclusion Daratumumab is highly effective and safe in the treatment of relapsed or refractory multiple myeloma.

Key words: Multiple myeloma, Relapsed or refractory multiple myeloma, Daratumumab, Treatment outcome, Adverse events

摘要： 背景　多发性骨髓瘤不可治愈，绝大多数患者终将复发。达雷妥尤单抗是一种人源化、抗CD38单克隆抗体，国外研究达雷妥尤单抗复发/难治性多发性骨髓瘤疗效显著，我国患者临床使用数据有限。目的　观察达雷妥尤单抗治疗复发/难治性多发性骨髓瘤临床疗效及不良反应。方法　回顾性分析北京积水潭医院血液科2019年10月—2020年6月接受达雷妥尤单抗治疗的9例复发/难治性多发性骨髓瘤患者临床资料，随访分析疗效及不良反应。结果　9例复发/难治性多发性骨髓瘤患者中7例可进行疗效评估，其中完全缓解（CR）2例（28.6%），非常好的部分缓解（VGPR）2例（28.6%），部分缓解（PR）1例（14.3%），微小缓解（MR）1例（14.3%），疾病稳定（SD）1例（14.3%），总体缓解率（ORR）71.4%（5/7）。常见的不良反应为血小板减少、中性粒细胞减少、淋巴细胞减少〔3~4级发生率分别为33.3%（3/9）、33.3（3/9）和55.6%（5/9）〕；输液相关不良反应发生率为44.4%（4/9）。结论　达雷妥尤单抗治疗复发/难治性多发性骨髓瘤具有较好的临床疗效、安全性好。

关键词: 多发性骨髓瘤, 复发/难治性多发性骨髓瘤, 达雷妥尤单抗, 治疗结果, 不良反应