New Protocol Reduces Adverse Effects In Use of Key Drug for Multiple Myeloma

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Fox Chase Cancer Center researchers have identified a pretreatment protocol that reduces side effects for the drug motixafortide, which is sold under the brand name Aphexda. The findings, which were presented today at the annual meeting of the American Society of Hematology, has significantly improved the comfort and quality of life for multiple myeloma patients undergoing autologous stem cell transplant.

“We’ve greatly reduced hypersensitivity and injection-site reactions and made the process of collecting stem cells a much more pleasant experience than it was with the recommended standard protocol,” said oncologist Peter Abdelmessieh, DO, MSc, the study’s lead author and an Assistant Professor in the Department of Bone Marrow Transplant and Cellular Therapies.

Approved for use by the Food and Drug Administration in 2023, motixafortide is given to patients to mobilize stem cells so they can be collected for transplant. Although it makes the process more efficient than an older drug, it also causes more severe reactions, Abdelmessieh noted.

Common reactions include irritation or rash at the injection site, as well as hypersensitivity symptoms including flushing, fatigue, headache, and shortness of breath. Although the reactions do not lead to hospitalization or prevent patients from completing the treatment, they have a significant negative effect on patients’ quality of life, he said.

The drug’s recommended premedication protocol includes a daily dose of loratadine, a common allergy drug, beginning three days before treatment, as well as an antihistamine, H2 blocker, leukotriene inhibitor, and acetaminophen about an hour before treatment.

“I was surprised at how many reactions we had even with the product insert recommendations, which is why we changed our management so quickly,” said Abdelmessieh, who conducted the study with other members of the Fox Chase – Temple University Hospital Bone Marrow Transplant Program.

He first added a low dose of dexamethasone, a steroid used to treat inflammation, to the pre-treatment regimen. Although five patients who received this protocol did better, they still had reactions. He then also added a five-day regimen of daily montelukast, a common drug used to treat stomach ulcers and acid reflux.

The 16 patients who received the new protocol, which he called MF-DEX, reported no grade 3 reactions and significantly fewer reactions overall. “I got the idea from seeing similar reactions with other drugs, mainly daratumumab,” which is also known by the brand name Darzalex, he said. “I essentially followed what worked with that drug.”

He decided to publish his results after seeing significant improvement in his patients under the new protocol. “This was more of a proactive measure to improve patient outcomes, and it was so successful we felt we had to publish it and let other providers know,” he said.

Abdelmessieh plans to continue following patient outcomes to document a larger patient population. He also hopes to investigate other agents as alternatives to steroids.

The research, “Comparative Analysis of Dexamethasone-Enhanced Pre-Medication in Motixafortide-Induced Hematopoietic Stem Cell Mobilization for Multiple Myeloma: A Retrospective Study,” was presented at the 66th ASH Annual Meeting and Exposition, which is being held December 7-10 in San Diego.