My study is about trying to decrease the grade 3 and 4 hypersensitivity and injection site reactions in patients being mobilised for stem cell transplantation.
What is the study design?
The study design is retrospective in nature at this point, which will lead to a prospective study that we’re currently trying to get funding for from the company that makes motixafortide. The design is essentially pre-medicating patients with a leukotriene inhibitor along with an H1 blocker three days prior to their injection. Then two hours prior to the injection using an H2 blocker, which is Benadryl, along with 8mg of dexamethasone two hours prior to their injection and continuing the montelukast, which is the leukotriene inhibitor, and Pepcid one day after stem cell collection. The design is for that to decrease grade 3 and 4 hypersensitivity and injection site reactions.
What were the results of this study?
The results show that in terms of hypersensitivity reactions we’ve decreased it to zero grade 3, grade 4, and only about 23% of grade 2 reactions. In terms of injection site reactions it has decreased from 100% to 50% in all grade reactions and only one out of 17 patients studied with this current design developed a greater than grade 2 injection site reaction. So a stark improvement in the quality of life of patients being mobilised for stem cell transplant.
What is the significance of these results?
The significance is essentially that patients that have to use this injection in order to mobilise their stem cells are now having less reactions and less toxicity with this prophylactic measure.
Is there anything else you would like to add?
It just shows the benefit of real world data versus the phase III data. The Genesis trial, which got this drug approved, saw similar events and did modify their prophylactic medications, however, in the real world it appears that patients are having a bit more toxicity than needed. The only thing I can do is I look forward to trying to work with the company to do a prospective trial better studying this combination and maybe considering other agents to help patients with infusion and injection site reactions.
