目的 探究达雷妥尤单抗（daratumumab,DARA）在治疗复发/难治性多发性骨髓瘤（relapsed/refractory multiple myeloma，R/RMM）的疗效及安全性。方法 回顾性分析2020年1月—2022年6月由我院收治的14例应用DARA治疗的R/RMM患者临床疗效、无进展生存期（progression free survival，PFS）、总反应率(overall response rate, ORR）及治疗期间安全性，男性8例，女性6例，中位年龄56.5（33~72）岁。结果 14例患者诊断分型IgA-κ型2例，IgA-λ型1例，IgG-κ型7例，IgG-λ型2例，非分泌型2例。5例接受2线治疗，6例接受3线治疗，3例接受4线治疗。14例患者至少完成第1疗程DARA治疗可进行疗效评估，其中5例完全缓解（complete response，CR），4例达到非常好的部分缓解（very good partial response，VGPR），2例达到部分缓解（partial remission，PR），3例达到疾病稳定（stable disease，SD）。13例存活，1例非治疗期间因肺部感染死亡。患者中位病程为29.5（10.0~96.0）个月，中位随访时间6（2~14）个月，中位PFS时间5（2~12）个月，ORR为78.6%。14例患者用药期间均未出现Ⅳ级不良反应，1例血压升高，1例频发室性期前收缩，不良反应均为Ⅰ级，积极治疗后不良反应均得到有效控制和改善。结论 R/RMM在常规治疗的基础上联合DARA可提高ORR及缓解深度，延长PFS，安全性较高并可增加患者临床获益，长期疗效仍有待进一步观察。

Objective To explore the efficacy and safety of daratumumab(DARA) in the treatment of relapsed/refractory multiple myeloma (R/RMM). Methods We retrospectively analyzed 14 patients treated with DARA, who were diagnosed with R/RMM at our hospital during January 2020 to June 2022. The clinical efficacy, progress free survival (PFS), overall response rate (ORR) and safety after treatment were evaluated. Results Total of 14 patients included 8 males and 6 females, in which the median age was 56.5(33-72) years, and the median disease duration was 29.5(10-96) months. The diagnostic classifications were 2 cases of IgA-κ type, 1 case of IgA-λ type, 7 cases of IgG-κ type, 2 cases of IgG-λ type, 2 cases of unsecretory type, respectively. In 14 patients, 5 patients received 2-line therapy in the past, 6 patients received 3-line therapy, and 3 patients received 4-line therapy. All 14 patients completed the first course of DARA treatment and the treatment efficacy was able to be evaluated. Among them, 5 patients achieved hematological complete response (CR), 4 patients achieved very good partial response (VGPR), 2 patients achieved partial response (PR) and 3 patients achieved stable disease(SD). Among them, 13 patients survived, and 1 patient died of lung infection during non-treatment period. The median duration of the disease was 29.5(10-96) months, the median follow-up time was 6(2-14) months, the PFS time was 5(2-12) months, and the ORR was 78.6%. There were no grade Ⅳ adverse reactions during the treatment period. Among them, blood pressure in 1 patient increased and frequent ventricular premature beats occurred in 1 patient. These adverse reactions were both grade Ⅰ adverse reactions., and could be effectively controlled and improved after active treatment. Conclusions R/RMM treated with DARA on the basis of conventional treatment can improve ORR and depth of remission and prolong the PFS of patients, and shows high safety; but its long-term efficacy still needs to be further observed.