Objective: This study aimed to evaluate the efficacy and safety of daratumumab as a maintenance treatment after autologous hematopoietic stem cell transplantation (auto-HSCT) in patients with newly diagnosed multiple myeloma (NDMM) . Methods: The clinical data, hematological and renal response, and safety of 15 post-transplant patients with NDMM who had received daratumumab maintenance between May 1, 2022 and June 30, 2023 were retrospectively analyzed. Results: Fifteen patients (11 males and 4 females) with a median age of 58 (41-72) years were included. Thirteen patients did not receive daratumumab during induction therapy and auto-HSCT, 6 patients had renal impairment, and nine patients had high-risk cytogenetics. The median infusion of daratumumab was 12 (6-17) times, and the median duration of maintenance was 6 (1.5-12) months. The treatment efficacy was evaluated in all 15 patients, and daratumumab maintenance therapy increased the rate of stringent complete response from 40% to 60%. The renal response rate and median estimated glomerular filtration rate of six patients with RI-NDMM were also improved. During daratumumab maintenance therapy, the most common hematological grade 3 adverse event (AE) was lymphopenia [4 of 15 patients (26.67%) ], whereas the most common nonhematologic AEs were infusion-related reactions [7 of 15 patients (46.67%) ] and grade 3 pneumonia [5 of 15 patients (33.33%) ]. The five patients with pneumonia were daratumumab naive [5 of 13 patients (38.46%) ], with a median of 8 (6-10) infusions. Among them, the chest computed tomography of three patients showed interstitial infiltrates, and treatment with methylprednisolone was effective. With a median follow-up of 12 months, the 1-year overall survival rate was 93.33%, and only one patient died (which was not related to daratumumab treatment) . Conclusions: Daratumumab was safe and effective as a maintenance agent for post-auto-HSCT patients with NDMM, and AEs were controllable. The most common nonhematologic AE was grade 3 pneumonia, and a less dose-intense maintenance regimen for the first 8 weeks could reduce the incidence of pneumonia.
目的： 探讨新诊断多发性骨髓瘤（NDMM）患者自体造血干细胞移植（auto-HSCT）后达雷妥尤单抗维持治疗的疗效及安全性。 方法： 回顾性分析2022年5月1日至2023年6月30日期间解放军总医院第五医学中心血液病医学部淋巴瘤-浆细胞疾病专科的15例NDMM患者auto-HSCT后接受达雷妥尤单抗维持治疗的临床资料、血液学及肾脏疗效、安全性。 结果： 15例患者中男11例，女4例，中位年龄58（41~72）岁；其中13例患者于诱导治疗及auto-HSCT阶段均未使用达雷妥尤单抗，6例伴有肾损害，9例遗传学高危。达雷妥尤单抗维持治疗的中位时间为6（1.5~12）个月，中位输注次数12（6~17）次。15例患者均可评估疗效，达雷妥尤单抗维持治疗使缓解深度增加，血液学严格意义的完全缓解率（sCR）由40%增加至60%；6例伴肾损害患者的肾脏缓解率由16.67%提升至33.33%。血液学3级以上不良事件（AE）主要为淋巴细胞减少（26.67%，4/15），非血液学AE主要为输注相关反应（46.67%，7/15）及3级肺炎（33.33%，5/15）。5例（38.46%，5/13）发生肺炎的患者均为达雷妥尤单抗初治者，发生时间在中位输注8（6~10）次，3例肺炎为肺间质改变，甲泼尼龙治疗有效。中位随访时间为12（7~13）个月，1例死亡（与达雷妥尤单抗治疗无关），1年总生存率为93.33%。 结论： 达雷妥尤单抗用于NDMM患者auto-HSCT后维持治疗可提高血液学及肾脏缓解率，且不良反应可控。主要的AE是3级肺炎，减少维持治疗期间前8周每周一次给药频次可能使肺炎发生率下降。.
Keywords: Autologous stem cell transplantation; Daratumumab; Maintenance therapy; Multiple myeloma.