Since its introduction in China in 2022, carfilzomib has been widely used in patients with relapsed and refractory multiple myeloma (RRMM), but there is a lack of research on its clinical efficacy and safety in the Chinese population with multiple myeloma (MM) .

To explore the efficacy and safety of carfilzomib in the treatment of MM.

This study included 53 cases MM patients who received at least two courses of carfilzomib treatment from March 2022 to September 2023 at Sichuan Provincial People's Hospital. Baseline data were collected, and all patients were treated with carfilzomib-based regimens. The starting point for follow-up was the first use of carfilzomib, and the endpoint was death, disease recurrence, or the end of follow-up. Patients were followed up through outpatient visits, hospital re-examinations, or phone calls every two months. The number of patients with stringent complete remission (sCR), complete remission (CR), very good partial remission (VGPR), partial remission (PR) and adverse reactions were recorded. The overall response rate (ORR), ≥VGPR rate, best ORR and best ≥VGPR rate were calculated to evaluate the clinical efficacy. The efficacy was analyzed in subgroups according to the number of treatment lines, extramedullary disease, Durie-Salmon (DS) staging, international staging system (ISS), renal function, and cardiovascular disease. The survival curves of progression-free survival (PFS) and overall survival (OS) were drawn by Kaplan-Meier method for survival analysis, and the survival curves were compared by Log-rank test.

After 2 courses of treatment, the PR was 17 cases (32.1%), VGPR was 11 cases (20.8%), CR was 4 cases (7.5%), sCR was 8 cases (15.1%), ORR was 75.5% (40/53). The overall efficacy evaluation showed that the best ORR was 84.9% (45/53) and the best ≥VGPR rate was 71.7% (38/53). There was no significant difference in the overall clinical efficacy between the first-line treatment group, the first recurrence treatment group and the third-line and above treatment group (P>0.05). There was statistically significant difference in PFS survival curve among the three groups (P<0.05). There was no significant difference in OS survival curve among the three groups (P>0.05). There were no significant differences in clinical efficacy, PFS and OS survival curves between mSMART standard risk group and high-risk group, DS stage Ⅰ-Ⅲ group, ISS stage Ⅰ-Ⅲ group, extramedullary disease group and non-extramedullary disease group, cardiovascular disease group and non-cardiovascular disease group, normal renal function group and abnormal renal function group (P>0.05). Among 53 patients, 8 cases (15.1%) had infection, 7 cases (1.2%) had adverse reactions such as hypertension, arrhythmia and heart failure, 3 cases (5.7%) had gastrointestinal adverse reactions such as nausea and vomiting, 1 case (1.9%) had liver function damage, and 1 case (1.9%) had renal function damage. The incidence of adverse reactions was 37.7% (20/53) .

Carfilzomib-based chemotherapy regimens have good clinical efficacy and high safety profiles, can serve as a preferred treatment option for MM patients.

卡非佐米自2022年在我国上市以来，已在复发难治性多发性骨髓瘤（RRMM）患者中广泛应用，但目前该药在我国多发性骨髓瘤（MM）患者中的临床有效性及安全性研究不足。

探讨卡非佐米治疗MM的临床疗效与安全性。

纳入2022年3月—2023年9月四川省人民医院接受至少2个疗程卡非佐米治疗的53例MM患者为研究对象，收集患者的基线资料，患者均采用以卡非佐米为基础的方案进行治疗，以研究对象首次使用卡非佐米的时间为随访起点，以死亡、疾病复发或随访结束为随访终点，通过门诊、住院复查或使用电话对患者进行随访，每2个月随访1次，并记录严格意义的完全缓解（sCR）、完全缓解（CR）、非常好的部分缓解（VGPR）、部分缓解（PR）以及发生不良反应患者例数，计算总缓解率（ORR）、≥VGPR率、最佳ORR和最佳≥VGPR率，评估临床疗效；根据患者的治疗线数、髓外病变、Durie-Salmon（DS）分期、国际分期系统（ISS）、肾功能、心血管疾病进行亚组间疗效分析；采用Kaplan-Meier法绘制患者无进展生存期（PFS）和总生存期（OS）生存曲线进行生存分析，生存曲线的比较采用Log-rank检验。

治疗2个疗程后，53例患者中PR为17例（32.1%），VGPR为11例（20.8%），CR为4例（7.5%），sCR为8例（15.1%），ORR为75.5%（40/53）。总体疗效评估显示，最佳ORR为84.9%（45/53），最佳≥VGPR率为71.7%（38/53）。一线用药组、首次复发用药组与三线及以上用药组总体临床疗效比较，差异无统计学意义（P>0.05）；三组患者PFS生存曲线比较，差异有统计学意义（P<0.05）；三组患者OS生存曲线比较，差异无统计学意义（P>0.05）；mSMART标危组与高危组、DS分期Ⅰ~Ⅲ组、ISS分期Ⅰ~Ⅲ组、有髓外病变组与无髓外病变组、有心血管疾病组与无心血管疾病组、肾功能正常组与异常组之间临床疗效、PFS、OS生存曲线比较，差异均无统计学意义（P>0.05）。53例患者中感染患者8例（15.1%），血压升高、心律失常、心衰加重等不良反应患者7例（1.2%），恶心、呕吐等胃肠道不良反应患者3例（5.7%），肝功能损害患者1例（1.9%），肾功能损害患者1例（1.9%）。不良反应发生率为37.7%（20/53）。

以卡非佐米为基础的化疗方案具有较好的临床疗效，且安全性高，可作为多发性骨髓瘤患者治疗的优选方案。