ASH 2020 | Fixed-volume isatuximab infusion in newly-diagnosed myeloma
Enrique M. Ocio, MD, PhD, Marqués de Valdecilla University Hospital, Santander, Spain, discusses a Phase Ib study (NCT02513186) evaluating the safety and activity of isatuximab (isa) combined with the current standard of care in patients with newly-diagnosed multiple myeloma who are transplant-ineligible: bortezomib (V), lenalidomide (R), and dexamethasone (d). Infusion reactions were recorded less frequently than in Part A of the study which used a weight-based volume infusion (26.1% vs 63.0%). The results obtained confirm the safety and feasibility of fixed-volume isa, but efficacy data are yet to be gathered. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Transcript (edited for clarity)
In this trial with Isa-VCd or Isa-VRd there was like, say it’s, I don’t know if it’s cell analysis, but we also had opportunity to test two different infusion methodology. One was the old one, it was a weight-based infusion methodology. While, here we are evaluating a different one, which is a volume-based infusion. And… Then we have a fixed volume, to infuse the isatuximab, and this was done in the last 46 patients that were enrolled in this trial...
In this trial with Isa-VCd or Isa-VRd there was like, say it’s, I don’t know if it’s cell analysis, but we also had opportunity to test two different infusion methodology. One was the old one, it was a weight-based infusion methodology. While, here we are evaluating a different one, which is a volume-based infusion. And… Then we have a fixed volume, to infuse the isatuximab, and this was done in the last 46 patients that were enrolled in this trial. And, I think there are two main messages here. What is the purpose of doing this fixed volume infusion is; one to make it simple, and avoid errors in administration, and the other one is to reduce the infusion duration. And this was achieved in fact, with this fixed volume infusion. The median duration of infusion of isatuximab decreased from 3.6 hours at the first infusion to 1.3 hours on the third infusion and onwards.
And in this case, as compared to the weight based infusion, it was from 1.3 and weight based was 2.5. So I think it’s, we are almost reaching to half, the duration of infusion from the third infusion and onwards. Also, importantly, there were less infusion reactions with the fixed volume from approximately 50, 51, 52% to 22%, a important decrease in the infusion reaction. So, we can say that we have a better way to administer the isatuximab, in this case is still IV, with a reduction of the duration, and also reduction in the infusion rate of reactions.
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