Objective: To investigate the efficacy and safety of daratumumab based regimens in relapse and/or refractory multiple myeloma (RRMM) in the real world, as well as the impact of daratumumab on stem cell collection and engraftment.
Methods: The clinical data of patients with RRMM who received daratumumab in hematology department of the First Affiliated Hospital of Xiamen University from February 2019 to March 2023 and had evaluable efficacy were retrospective analysis.
Results: All 43 RRMM patients were treated with daratumumab-based combination regimens, including Dd, DVd, DRd, Dkd, DId, and Dara-DECP. With median follow-up time 10.1 (2.1-36.6) months, the best overall response rate (ORR) was 74.4% and a best complete response rate (CR) was 25.6%. 1-year overall survival rate (OS) was 84.5%. The most common severe hematologic adverse events (Grade>3) are 3/4 grade leukopenia（18.6%）, and the most common severe non-hematologic adverse events were infusion-related reactions (IRRs， 20.9%) and infections（7.0%）. Multivariate prognostic analysis showed that extramedullary infiltration was an independent adverse prognostic factor affecting OS （P =0.004）. The use of daratumumab has no effect on stem cell collection, or engraftment.
Conclusion: Daratumumab is safe and effective in RRMM.
题目: 达雷妥尤单抗为基础的方案治疗复发难治性多发性骨髓瘤的有效性及安全性：单中心真实世界数据.
目的: 探讨真实世界中以达雷妥尤单抗为基础的方案治疗复发难治性多发性骨髓瘤（RRMM）的有效性和安全性，以及达雷妥尤单抗应用对干细胞采集和植入的影响。.
方法: 回顾性分析2019年2月至2023年3月厦门大学附属第一医院血液科接受达雷妥尤单抗治疗且可评估疗效的RRMM患者的临床数据。.
结果: 纳入的43例RRMM患者均采用以达雷妥尤单抗为基础的联合方案进行治疗，包括Dd、DVd、DRd、Dkd、DId、Dara-DECP，中位随访时间10.1（2.1-36.6）个月,最佳总缓解率（ORR）为74.4%，最佳完全缓解率（CR）为25.6%，1年总生存率（OS）为84.5%。最常见的3/4级血液学不良反应为白细胞减少(18.6%)，最常见的非血液学不良反应主要为输注相关反应（IRRs，20.9%）和感染（7.0%）。多因素预后分析显示髓外浸润是影响患者OS的独立不良预后因素（P =0.004）。使用达雷妥尤单抗对干细胞采集及移植后干细胞重建没有影响。.
结论: 达雷妥尤单抗治疗RRMM安全有效。.
Keywords: relapse/refractory multiple myeloma; daratumumab; efficacy; stem cell collection and engraftment.