Abstract
BackgroundThe 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.MethodsWe 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.ResultsA 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.ConclusionsOur 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.
Highlights
Daratumumab is a fully human, IgG kappa monoclonal antibody targeting CD38 expressed by plasma cells
Study Design and Patient Selection. This was a retrospective, multicenter, observational study aiming to evaluate the safety of the rapid, 90-minute daratumumab infusion in RRMM patients treated in three Italian hospitals (Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino; IRCCS Azienda OspedalieroUniversitaria di Bologna, Bologna; and Azienda OspedaleUniversità di Padova, Padova, Italy) after its implementation in clinical practice
As in the study conducted by Barr et al in our study the rapid daratumumab infusions were administered with 20% of the total dose delivered in 30 minutes (200 mL/hr) and the remaining 80% in the following 60 minutes (450 mL/hr) [9]
Summary
Daratumumab is a fully human, IgG kappa monoclonal antibody targeting CD38 expressed by plasma cells. In several phase III trials, the addition of daratumumab to standard anti-multiple myeloma (MM) regimens reduced the risk of disease progression or death by 45-60% in both newly diagnosed (ND)MM and relapsed/refractory (RR)MM patients, as compared to control arms [1–6]. Based on these results, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved daratumumab as monotherapy first and in combination with lenalidomidedexamethasone (Dara-Rd), bortezomib-dexamethasone (Dara-Vd), pomalidomide-dexamethasone (Dara-Pd, by the FDA only), or carfilzomib-dexamethasone (Dara-Kd, by the FDA only) in the relapse setting and as first-line treatment in combination with bortezomib-melphalan-prednisone (Dara-VMP) or Rd (Dara-Rd) for transplant-ineligible patients and with bortezomib-thalidomidedexamethasone (Dara-VTd) for transplant-eligible patients. The rapid schedule was adopted by our centers since 2019
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
