Safety of Rapid Daratumumab Infusion: A Retrospective, Multicenter, Real-Life Analysis on 134 Patients With Multiple Myeloma.

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Informations de copyright

Copyright © 2022 Bonello, Rocchi, Barilà, Sandrone, Talarico, Zamagni, Scaldaferri, Vedovato, Bertiond, Pavan, Bringhen, Cattel, Zambello, Cavo and Mina.

Déclaration de conflit d'intérêts

Author SR has received honoraria from Janssen, Bristol Myers Squibb, Amgen, and GlaxoSmithKline. Author GB has served on the advisory boards for Janssen and Amgen. Author EZ has received honoraria from and served on the advisory boards for Janssen, Bristol Myers Squibb, Takeda, Sanofi, Amgen, GlaxoSmithKline, and Oncopeptides. Author SB has received honoraria from Celgene, Amgen, Oncopeptides, Janssen, and Sanofi; has served on the advisory boards for Takeda, Janssen, GlaxoSmithKline, Sanofi, Bristol Myers Squibb, and Oncopeptides; has received consultancy fees from Janssen, Takeda, Amgen, and Sanofi. Author RZ has served on the advisory boards for Celgene, Janssen, ​GlaxoSmithKline, Amgen, and Takeda. Author MC has received honoraria from Janssen, Celgene, Bristol Myers Squibb, GlaxoSmithKline, Amgen, Takeda, AbbVie, Sanofi, and Roche; has served on the advisory boards for Janssen, Celgene, Bristol Myers Squibb, GlaxoSmithKline, Amgen, Takeda, AbbVie, Sanofi, Roche, and Adaptive Biotechnologies. Author RM has received honoraria from Sanofi, Celgene, Takeda, and Janssen; has served on the advisory boards for Sanofi, Takeda, Bristol Myers Squibb, and Janssen; has received consultancy fees from Janssen. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.