Bonello Francesca, Rocchi Serena, Barilà Gregorio, Sandrone Michela, Talarico Marco, Zamagni Elena, Scaldaferri Matilde, Vedovato Susanna, Bertiond Cecilia, Pavan Laura, Bringhen Sara, Cattel Francesco, Zambello Renato, Cavo Michele, Mina Roberto
SSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Front Oncol. 2022 Mar 14;12:851864. doi: 10.3389/fonc.2022.851864. eCollection 2022.
The anti-CD38 monoclonal antibody daratumumab is the backbone of most anti-multiple myeloma (MM) regimens. To mitigate the risk of infusion-related reactions (IRRs), intravenous daratumumab administration requires 7 hours for the first infusion and 3.5-4 hours thereafter, thus making daratumumab-containing regimens burdensome for patients and health care resources. Preliminary data suggest that a rapid (90-minute) infusion of daratumumab is safe and does not increase IRRs. The rapid schedule was adopted by our centers since 2019.
We conducted an observational multi-center, real-life study to assess the safety of rapid daratumumab infusion protocol from the third administration in relapsed MM patients receiving daratumumab alone or in combination with lenalidomide-dexamethasone or bortezomib-dexamethasone. The primary endpoint was the safety of the rapid infusion protocol, particularly in terms of IRRs.
A total of 134 MM patients were enrolled. IRRs occurred in 7 (5%) patients and were mostly mild (6/7 of grade 1-2), with only 1 patient experiencing a grade 3 IRR. Due to the IRRs, 5 (3.7%) patients discontinued the rapid infusions and resumed daratumumab at the standard infusion rate, while 1 patient permanently discontinued daratumumab. In 4/7 patients (57%), IRRs occurred while resuming rapid daratumumab infusions after a temporary interruption (2-4 months). No other adverse event was considered related to the rapid infusion protocol.
Our findings confirmed the safety of rapid daratumumab infusions starting from the third administration. In case of prolonged daratumumab interruption, it is advisable to resume infusions at the standard rate (3.5 hours) before switching to the rapid infusion.
抗CD38单克隆抗体达雷妥尤单抗是大多数抗多发性骨髓瘤（MM）方案的核心药物。为降低输液相关反应（IRR）的风险，静脉注射达雷妥尤单抗时，首次输注需要7小时，之后每次输注需要3.5至4小时，因此含达雷妥尤单抗的方案给患者和医疗资源带来了负担。初步数据表明，快速（90分钟）输注达雷妥尤单抗是安全的，且不会增加IRR。自2019年起，我们中心采用了快速输注方案。
我们进行了一项多中心、真实世界的观察性研究，以评估在复发MM患者中，从第三次给药开始快速输注达雷妥尤单抗方案的安全性，这些患者单独接受达雷妥尤单抗治疗，或与来那度胺-地塞米松或硼替佐米-地塞米松联合使用。主要终点是快速输注方案的安全性，特别是在IRR方面。
共纳入134例MM患者。7例（5%）患者发生了IRR，大多数为轻度（1-2级的6/7），只有1例患者发生3级IRR。由于IRR，5例（3.7%）患者停止快速输注，以标准输注速率恢复使用达雷妥尤单抗，而1例患者永久停用达雷妥尤单抗。在7例患者中的4例（57%）中，IRR发生在暂时中断（2-4个月）后恢复快速输注达雷妥尤单抗时。没有其他不良事件被认为与快速输注方案有关。
我们的研究结果证实了从第三次给药开始快速输注达雷妥尤单抗的安全性。如果达雷妥尤单抗长时间中断，建议在切换至快速输注之前，先以标准速率（3.5小时）恢复输注。
