Department of Pharmacy, University Hospital, Dijon, France.
Department of Pharmacy, University Hospital, and EPICAD LNC UMR1231, University of Burgundy & Franche Comte, Dijon, France.
J Oncol Pharm Pract. 2021 Jul;27(5):1080-1085. doi: 10.1177/1078155220951231. Epub 2020 Aug 30.
Daratumumab is the first anti-CD38 monoclonal antibody of the class approved for recurrent and refractory multiple myeloma. Grade 3 and 4 Infusion-Related Reactions (IRRs) are frequent during the first and second infusions. Due to the risks associated with severe IRRs, daratumumab is systematically administered over a period of 3.5 hours.The main objective of this study was to evaluate the safety of a 90-minute daratumumab infusion from the third infusion.
All patients who had received two or more doses of daratumumab in monotherapy or in combination with standard infusion rates were included. We excluded patients enrolled in clinical trials. For the rapid infusion protocol, 20% of the dose was administered over 30 minutes and the remaining 80% over 60 minutes.
From April 1 to May 31, 2019, 25 patients received 53 90-minute infusions of daratumumab. Premedication included corticosteroids, antipyretics, antihistamines, and if necessary a leukotriene receptor antagonist. No grade 3 or grade 4 IRRs were observed.
From the third infusion, we found that a rapid administration of daratumumab (90 vs 210 minutes) was well tolerated and safe. It would be interesting to test this regimen from the second infusion.
达雷妥尤单抗是首个获批用于复发性和难治性多发性骨髓瘤的抗 CD38 单克隆抗体。在首次和第二次输注期间，经常会出现 3 级和 4 级输注相关反应（IRR）。由于严重 IRR 相关的风险，达雷妥尤单抗的给药时间被系统地设定为 3.5 小时。本研究的主要目的是评估从第三次输注开始的 90 分钟达雷妥尤单抗输注的安全性。
所有接受过两次或更多剂量达雷妥尤单抗单药治疗或与标准输注率联合治疗的患者均被纳入本研究。我们排除了参加临床试验的患者。对于快速输注方案，20%的剂量在 30 分钟内输注，其余 80%在 60 分钟内输注。
从 2019 年 4 月 1 日至 5 月 31 日，共有 25 名患者接受了 53 次 90 分钟达雷妥尤单抗输注。预处理包括皮质类固醇、解热药、抗组胺药，如果需要，还包括白三烯受体拮抗剂。未观察到 3 级或 4 级 IRR。
从第三次输注开始，我们发现快速输注达雷妥尤单抗（90 分钟与 210 分钟）具有良好的耐受性和安全性。从第二次输注开始测试这种方案将很有趣。
