Background and importance Daratumumab is an anti-CD38 monoclonal antibody now extensively used for multiple myeloma. Due to the high risk of infusion related reactions (IRRs), it is administered over a period of 4 hours. The French Myeloma Intergroup, as part of COVID-19, has authorised infusions of daratumumab over 1.5 hours in clinical trials (CT) based on studies showing a safety profile comparable with long infusions.
Aim and objectives The aim of this study was to evaluate IRRs associated with rapid injection of daratumumab in a real life population.
Material and methods From June to July 2020, after medical approval, patients who were given two or more doses of daratumumab with standard infusion rates were authorised to receive ‘rapid dara’ (infusion 1.5 hours). A group was organised by the pharmacy for the nursing team to present the new infusion rate and to remind them of the risks of IRRs. Patient characteristics (age, sex, comorbidities), previous daratumumab infusions (including if patients experienced IRRs) and type of protocols were collected. IRRs were directly recorded in validation administration software.
Results 23 patients received ‘rapid dara’ during the study period and no IRRs were reported. Mean age was 69.5 years; 5/23 patients were between 45 and 65 years old, 13/23 between 65 and 75 years old and 5/23 were >75 years old. 15/23 were women and 8/23 were men. 15/23 patients had at least one comorbidity; 13/23 had at least one cardiovascular comorbidity, 3/23 had one pneumological comorbidity and 6/23 had renal impairment. In terms of treatment, 21/23 patients were receiving multidrug therapy (compared with 2/23 on daratumumab monotherapy). 6/23 had previously received between 3 and 10 INJ, 14/23 between 11 and 20 INJ and 3/23 had received >20 INJ.
Conclusion and relevance Our findings suggest that in real life patients, ‘rapid dara’ is safe in terms of IRRs. These results are in agreement with those presented in previous CT. In the context of the COVID-19 crisis, decreased infusion time allows a reduction in contact time, decreased hospitalisations, and optimises nurse timing. Rapid daratumumab appears to be a safe and economic alternative while waiting for subcutaneous daratumumab.
Conflict of interest No conflict of interest
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