近年来，引入了几种双特异性抗体（BsAbs），彻底改变了多发性骨髓瘤（MM）患者的治疗方法。本研究旨在进行系统综述和荟萃分析，评估BsAbs在MM患者中的安全性和疗效。我们于2022年6月10日系统地搜索了PubMed、Scopus、Web of Science和Embase数据库。通过标题/摘要和全文筛选进行两步选择相关文章。主要终点考虑评估BsAbs的安全性，通过检查血液学和非血液学不良反应（AE）的发生率进行评估。次要观察指标设定在通过汇总客观缓解率（ORR）、（严格）完全缓解（sCR/CR）、很好的部分缓解（VGPR）和部分缓解（PR）来评估BsAbs的疗效。共有11篇文献和9种可评估的BsAbs被纳入定性和定量数据综合分析。与非血液学事件相比，血液学AE在患者中更常见，其中最常见的事件是贫血（41.4%）、中性粒细胞减少（36.4%）和血小板减少（26.3%）。最常见的非血液学AE是感染，在患者中发生率为39.9%，其次是味觉异常（28.3%）、疲劳（26.5%）和腹泻（25.8%）。此外，8.1%的患者出现免疫效应细胞相关的神经毒性综合征，5.1%的患者出现神经毒性。此外，59.8%的患者出现细胞因子释放综合征。BsAbs相关死亡率估计为0.1%。就疗效措施而言，MM患者中ORR达到62.6%，sCR/CR、VGPR和PR的汇总率分别为22.7%、23.0%和12.1%。在多个新兴有希望的MM治疗方法出现的时代，BsAbs在经过重度前期治疗的患者中取得了较高的ORR和可耐受的AE。然而，仍有开发具有更低AE发生率且能够绕过肿瘤逃避机制的BsAbs的空间。©2023. BioMed Central Ltd.，Springer Nature的一部分。

In recent years, several bispecific antibodies (BsAbs) have been introduced that revolutionized the treatment approach for patients with multiple myeloma (MM). In the present study, we sought for conducting a systematic review and meta-analysis with the aim of evaluating the safety and efficacy of BsAbs in MM patients.PubMed, Scopus, Web of Science, and Embase databases were systematically searched on June 10, 2022. Two steps of title/abstract and full-text screening were performed for selecting the relevant articles. The primary endpoint was considered to evaluate the safety of BsAbs by examining the rate of hematologic and non-hematologic adverse effects (AEs). The secondary outcome was set at the efficacy of BsAbs through pooling objective response rate (ORR), (stringent) complete response (sCR/CR), very good partial response (VGPR), and partial response (PR).Eleven publications with a total of nine evaluable BsAbs were included for qualitative and quantitative data synthesis. Hematologic AEs were more common among patients than non-hematologic events, with the most frequent events being anemia (41.4%), neutropenia (36.4%), and thrombocytopenia (26.3%). The most common non-hematological AE was infection, which occurred in 39.9% of patients, followed by dysgeusia (28.3%), fatigue (26.5%), and diarrhea (25.8%). Besides, 8.1% of patients experienced immune effector cell-associated neurotoxicity syndrome and neurotoxicity occurred in 5.1% of them. Moreover, 59.8% of patients experienced cytokine release syndrome. The pooled rate of deaths attributable to BsAbs was estimated at 0.1%. In terms of efficacy measures, the ORR was achieved in 62.6% of MM patients, and the pooled rates of sCR/CR, VGPR, and PR were 22.7%, 23.0%, and 12.1%, respectively.In an era with several emerging promising treatments for MM, BsAbs have achieved a high ORR and tolerable AEs in heavily pretreated patients. However, there is still room for developing BsAbs with a lower rate of AEs and capable of bypassing tumor evasion mechanisms.© 2023. BioMed Central Ltd., part of Springer Nature.