Multiple Myeloma GIMEMA Lazio Group, Via Casilina 5, 00182, Rome, Italy.
Ann Hematol. 2021 Apr;100(4):1059-1063. doi: 10.1007/s00277-020-04374-y. Epub 2021 Feb 2.
Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors (PI) and immunomodulatory drugs (IMiDs). However, there are limited data on its clinical activity and tolerability in real-world patients. Therefore, in the present study, we aim to determine the efficacy and toxicity profile of daratumumab in a real-life setting. In this study, we report the experience of the multiple myeloma GIMEMA Lazio Group in 62 relapsed/refractory MM patients treated with daratumumab as monotherapy who had previously received at least two treatment lines including a PI and an IMiDs or had been double refractory. Patients received DARA 16 mg/kg intravenously weekly for 8 weeks, every 2 weeks for 16 weeks, and every 4 weeks until disease progression or unacceptable toxicity. The overall response rate to daratumumab was 46%. Median progression-free survival (PFS) and overall survival reached 2.7 and 22.4 months, respectively. DARA was generally well tolerated; however, 2 patients interrupted their therapy due to adverse events. Present real-life experience confirms that DARA monotherapy is an effective strategy for heavily pre-treated and refractory patients with multiple myeloma, with a favorable safety profile.
达雷妥尤单抗（DARA）是一种针对 CD38 的人 IgG-K 单克隆抗体（MoAb），已获批单独使用或与硼替佐米和地塞米松或来那度胺和地塞米松联合用于先前接受过蛋白酶体抑制剂（PI）和免疫调节药物（IMiDs）治疗或双重难治的复发/难治性多发性骨髓瘤（RRMM）患者。然而，在真实患者中，关于其临床疗效和耐受性的数据有限。因此，在本研究中，我们旨在确定达雷妥尤单抗在真实环境中的疗效和毒性特征。在这项研究中，我们报告了多发性骨髓瘤 GIMEMA Lazio 组在 62 例复发/难治性多发性骨髓瘤患者中的经验，这些患者之前接受过至少两种治疗方案，包括 PI 和 IMiDs，或已经双重难治。患者接受达雷妥尤单抗 16 mg/kg 静脉注射，每周一次，连续 8 周，每 2 周一次，共 16 周，每 4 周一次，直到疾病进展或不可接受的毒性。达雷妥尤单抗的总体缓解率为 46%。中位无进展生存期（PFS）和总生存期分别达到 2.7 个月和 22.4 个月。达雷妥尤单抗总体耐受性良好；然而，有 2 名患者因不良事件中断治疗。目前的真实世界经验证实，达雷妥尤单抗单药治疗对经过大量预处理和难治的多发性骨髓瘤患者是一种有效的策略，具有良好的安全性特征。
