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Safety of Daratumumab in Relapsed or Refractory Multiple Myeloma

By: Sarah Campen, PharmD
Posted: Tuesday, December 4, 2018

An early access treatment protocol study of daratumumab in patients with relapsed or refractory multiple myeloma has confirmed the safety profile of this agent from previously reported trials, according to Ajai Chari, MD, of Mount Sinai Medical Center, New York, and colleagues. Additionally, they discovered that premedicating patients with montelukast before infusion of daratumumab appears to significantly reduce infusion reactions. The results of the study were published in Cancer.

The multicenter, open-label treatment protocol provided early access to daratumumab for 348 patients with progressive multiple myeloma after receiving at least 3 previous lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Patients received study therapy for a median of 1.9 months; 52% of patients transitioned to commercially available daratumumab and 37% discontinued treatment because of progressive disease.

As for safety, grade ≥ 3 adverse events occurred in 50% of patients, including thrombocytopenia (15%) and anemia (14%). Serious adverse events were seen in 35% of patients, with 12 considered to be related to the use of daratumumab. Infusion reactions occurred in 56%, 2%, and 2% of patients during the first, second, and all subsequent infusions, respectively. The most frequently reported infusion reactions were chills (15%), cough (14%), and dyspnea (9%).

In 50 patients who received montelukast as premedication, the infusion reaction rate for the first infusion was 38%, compared with 59% in patients who did not receive montelukast. Additionally, the incidence of grade 3 and 4 infusion reactions was 2% and 9%, respectively. “The findings indicate that further investigation of montelukast premedication to reduce [immune reactions] is warranted, and formal studies of montelukast as a premedication for daratumumab are ongoing,” concluded the authors.



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