Accelerated daratumumab infusion safe, well tolerated in multiple myeloma

Accelerated administration of daratumumab, an anti-CD3 monoclonal antibody approved for multiple myeloma, is safe and well tolerated when given following at least two standard infusions, suggest the results of a recent study.

“The initial infusion is administered over a median of 7.5 hours with subsequent infusions given over 3 to 4 hours,” the researchers said. “Studies show high incidence of infusion-related reactions (IRRs) with the initial dose, which decreases with subsequent infusions.”

This study was performed with the aim of evaluating the safety of accelerated daratumumab infusions relative to standard administration. The incidence of common terminology criteria for adverse events (CTCAE) version 5.0 grade 1 or higher for IRRs in both infusions was the primary outcome. Secondary outcomes were non-IRR adverse events and amount of supportive care medications used pre-, post-, and during accelerated and standard administration.

Seventy-five patients were administered daratumumab between November 2015 and August 2019. A total of 420 daratumumab infusions were assessed, of which 317 (75.5 percent) were standard infusions; of these, 152 were standard administration that preceded an accelerated infusion. Overall, 103 (24.5 percent) accelerated infusions were recorded.

IRRs occurred in 38 (9 percent) of the infusions, with CTCAE grade 2 reactions seen in 21 (5 percent) infusions and grade 1 in 15 (3.6 percent).

“Accelerated 90-minute daratumumab infusions following the second dose of standard administration are widely accepted in practice … despite limited data from small safety studies,” the researchers said.