Multiple myeloma (MM) is a common hematologic malignancy. With the emergence of a variety of new drugs, the survival rates of patients have increased, however, further discussion on how to achieve deeper and faster remission and reduce recurrence of patients is still needed.

To investigate the efficacy and safety of daratumumab in the chemotherapy of MM.

73 MM patients treated with daletumab in Sichuan Provincial People's Hospital from January 2020 to July 2022 were included as study subjects. Baseline information of the included patients were collected through the electronic medical record system. All patients were treated with daletumab based regimen and followed up through outpatient and inpatient review and telephone once a month when it is not time for review, with the time of first use of darettuzumab since 2020-01-01 as the starting point, death, disease recurrence or end of follow-up as the ending point. Follow-up was up to 2022-07-31 with a median follow-up time of 6.5 (0.5, 26.5) months. Overall response rate (ORR) and complete response rate were used to evaluate the efficacy of the patients. Kaplan-Meier curves were plotted for different drug use, initial renal function, drug administration, cytogenetic risk stratification and M protein types, and compared by Log-rank test.

The median age of the patients was 64 (30, 86) years, including 38 males and 35 females. 28 MM patients were treated with first-line darettuzumab, 13 were switched from other regiments to darettuzumab due to adverse reactions, and 32 patients had relapsed and refractory multiple myeloma (RRMM). 18 patients were lost during follow-up, and a total of 55 patients were available for efficacy assessment. After one course of treatment with the darettuzumab-based chemotherapy regimen, ORR was 72.7% with the complete response rate of 30.9%, including 3.6% (2/55) achieved strin-gent complete response (sCR) and 27.3% (15/55) achieved complete response (CR), 10.9% (6/55) achieved very good partial response (VGPR), 30.9% (17/55) achieved partial response (PR), 9.1% (5/55) achieved minimal response (MR), 12.7% (7/55) achieved stable disease (SD), and 5.5% (3/55) achieved disease progression (PD). The median progress free survival (PFS) of the patients was 6.0 (0.5, 26.5) months, and the median overall survival was 16 (3, 103) months. There was no statistically significant difference in the PFS survival curve between patients treated first-line with darettuzumab and RRMM patients (χ²=3.676, P=0.055). The difference of PFS survival curve between patients with normal and impaired renal function was statistically significant (χ²=12.51, P=0.004). There was a statistically significant difference in the survival curve of patients treated with daletumab + bortezomib + dexamethasone and those treated with daletumab + dexamethasone (χ²=6.691, P=0.009). There was no statistically significant difference in PFS survival curves between patients with non-high risk and high-risk cytogenetic classification (χ²=0.328, P=0.567). There was no statistically significant difference in PFS survival curves among patients with M protein types of IgA, IgG, IgD, light chain, double clone and non-secretory (P>0.05). The main adverse reactions of the patients were infusion reaction and myelosuppression, of which 21 patients had adverse infusion reactions at the first infusion, 21 patients had leukopenia, 40 patients had anemia and 16 patients had thrombocytopenia.

Darettuzumab has good curative effect in MM patients, which can be used as the first-line treatment for newly diagnosed patients, improve the clinical prognosis of RRMM patients, and prolong the survival time of patients.

多发性骨髓瘤（MM）是一种常见的血液系统肿瘤，随着各种新药出现，患者生存率升高，但如何使患者更大程度达到缓解，减少复发，还需要进一步探讨。

探讨达雷妥尤单抗治疗MM的疗效与安全性。

纳入2020年1月至2022年7月四川省人民医院接受达雷妥尤单抗治疗的73例MM患者为研究对象，通过电子病历系统收集患者的基线资料，所有患者采用以达雷妥尤单抗为基础的方案进行治疗，通过门诊、住院复查或使用电话对患者进行随访，每月随访1次，以观察对象自2020-01-01起首次使用达雷妥尤单抗的时间为随访起点，以死亡、疾病复发或随访结束为随访终点。随访截至2022-07-31，中位随访时间6.5（0.5，26.5）个月，以总缓解率（ORR）、完全缓解率评估患者疗效。绘制不同用药情况、不同初诊肾功能情况、不同给药情况、细胞遗传学不同危险度分层、不同M蛋白类型的Kaplan-Meier曲线，生存曲线的比较采用Log-rank检验。

患者中位年龄为64（30，86）岁，其中男38例，女35例。28例MM患者一线使用达雷妥尤单抗，13例因不良反应从其他方案换用达雷妥尤单抗，32例患者为复发难治性多发性骨髓瘤（RRMM）。随访过程中18例患者失访，可进行疗效评估的患者共55例。使用达雷妥尤单抗为基础的联合用药方案治疗1个疗程后，ORR 72.7%，完全缓解率30.9%，其中3.6%（2/55）达到严格意义的完全缓解（sCR），27.3%（15/55）达到完全缓解（CR），10.9%（6/55）达到非常好的部分缓解（VGPR），30.9%（17/55）达到部分缓解（PR），9.1%（5/55）达到微小缓解（MR），12.7%（7/55）达到疾病稳定（SD），5.5%（3/55）达到疾病进展（PD）。患者中位无进展生存期（PFS）为6.0（0.5，26.5）个月，中位总生存期为16（3，103）个月。一线使用达雷妥尤单抗患者与RRMM患者PFS的生存曲线比较，差异无统计学意义（χ²=3.676，P=0.055）；肾功能正常与肾功能受损患者PFS生存曲线比较，差异有统计学意义（χ²=12.51，P=0.004）；采用达雷妥尤单抗+硼替佐米+地塞米松方案与采用达雷妥尤单抗+地塞米松方案患者PFS生存曲线比较，差异有统计学意义（χ²=6.691，P=0.009）；细胞遗传学分级非高危与高危患者PFS生存曲线比较，差异无统计学意义（χ²=0.328，P=0.567）；M蛋白类型IgA型、IgG型、IgD型、轻链型、双克隆型、未分泌型患者的PFS生存曲线比较，差异均无统计学意义（P>0.05）。患者主要不良反应为输注反应及骨髓抑制，其中21例患者在第一次输注时出现输注不良反应，21例患者出现白细胞减少，40例患者出现贫血，16例患者出现血小板减少。

达雷妥尤单抗在MM患者中疗效较好，可作为初诊患者的一线治疗方案，也可改善RRMM患者的临床预后，可延长患者的生存时间。