Daratumumab-based therapy has been shown to have significant clinical efficacy in phase 3 trials of patients with relapse or refractory multiple myeloma. Outside of clinical trials, however, clinical data on daratumumab remain limited. We reviewed medical records of patients who received daratumumab combination therapy at our institute (median age 74 years; median lines of prior therapy 4). The overall response rate was 69.4%, and 36.7% of patients achieved complete response (CR) or better. The proportion of patients who attained CR or better was significantly higher among patients with < 4 prior therapies than those with ≥ 4 (56.5% vs 19.2%, P = 0.009). Estimated median progression-free survival (PFS) was 12.4 months (95% confidence interval 8.6-not reached). The median PFS was significantly worse in patients who were refractory to bortezomib and lenalidomide and had received ≥ 4 lines of prior therapy. Twelve of 49 patients attained negative minimal residual disease. Common adverse events included hematological toxicities including neutropenia and lymphopenia; however, the rate of febrile neutropenia was low (3.8%). Infusion-related reactions occurred in 32.1% of patients, but were grade 1 or 2. Daratumumab combination therapies therefore appear to be effective and safe as salvage regimens in clinical practice, especially when used in the early phase.

中文翻译：

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在临床试验之外评估daratumumab的安全性和有效性。

在患有复发或难治性多发性骨髓瘤的患者的3期试验中，基于Daratumumab的疗法已显示出显着的临床疗效。但是，在临床试验之外，有关daratumumab的临床数据仍然有限。我们回顾了我院接受达拉他单抗联合治疗的患者的病历（中位年龄74岁；中位治疗水平4）。总体缓解率为69.4％，并且36.7％的患者达到了完全缓解（CR）或更高。接受<4次治疗的患者中达到CR或更高水平的患者比例显着高于≥4个患者（56.5％比19.2％，P = 0.009）。估计中位无进展生存期（PFS）为12.4个月（95％置信区间8.6-未达到）。对硼替佐米和来那度胺难治且接受过≥4线先前治疗的患者，中位PFS显着恶化。49名患者中有12名获得最小残留病阴性。常见的不良事件包括血液毒性，包括中性粒细胞减少和淋巴细胞减少。然而，发热性中性粒细胞减少症的发生率较低（3.8％）。输注相关反应发生在32.1％的患者中，但属于1或2级。因此，Daratumumab联合疗法在临床实践中尤其是在早期使用时，作为挽救方案似乎是有效和安全的。发热性中性粒细胞减少症的发生率较低（3.8％）。输注相关反应发生在32.1％的患者中，但属于1或2级。因此，Daratumumab联合疗法在临床实践中尤其是在早期使用时，作为挽救方案似乎是有效和安全的。发热性中性粒细胞减少症的发生率较低（3.8％）。输注相关反应发生在32.1％的患者中，但属于1或2级。因此，Daratumumab联合疗法在临床实践中尤其是在早期使用时，作为挽救方案似乎是有效和安全的。