Real-World Utilization And Safety Of Daratumumab Rapid Infusion Administered In A Community Setting: A Retrospective Observational Study

BLOOD(2019)

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摘要
Introduction: Daratumumab (dara), a CD38-directed monoclonal antibody, was first FDA approved as monotherapy in 2015 for the treatment of patients with relapsed refractory multiple myeloma (RRMM) and has subsequently received approval for combination therapy for RRMM and newly diagnosed transplant ineligible MM1. In clinical trials, median durations of 16 mg/kg infusions for the 1st, 2nd, and subsequent infusions were ~7, 4, and 3 hours, respectively. In 2019, FDA approved split-dosing of the first 16 mg/kg dose and some institutions, including Florida Cancer Specialists & Research Institute (FCS), have also implemented a dara rapid infusion [RI] protocol in which patients can receive dara RI (≤90 minutes infusion duration) after having received ≥2 prior dara doses without any infusion reactions (IRs) and with pre-medications as per institutional guidelines. The objective of this study was to better understand the utilization and IRs observed among patients who received dara RI in routine care.
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