Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-12-31

Summary

This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. MM patients that receive an autologous stem cell transplantation (ASCT) have better outcomes. However, not all MM patients are able to have a successful stem cell mobilization and collection which is needed to proceed to ASCT. The addition of motixafortide prior to stem cell mobilization has allowed more MM patients to collect the needed number of stem cells to proceed to ASCT. However, motixafortide does produce systemic and injection site reactions in many patients. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of allergic reaction in many patients and is considered the standard of care regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen side effects/allergic reactions. However, dexamethasone is associated with other side effects like headache, difficulty sleeping, high blood glucose, high blood pressure, mood changes, fluid retention, and infection, among others. Thus, the optimal premedication regimen to prevent allergic reactions with motixafortide while avoiding other side effects remains uncertain. It is thought a premedication regimen with methylprednisolone prior to motixafortide may work better to decrease the incidence of reactions to motixafortide in patients with MM undergoing stem cell mobilization. Methylprednisolone is in a class of medications called corticosteroids. It works to decrease side effects/allergic reactions by changing the way the immune system works. Giving methylprednisolone may be safe, tolerable and/or more effective than dexamethasone as part of a premedication regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization.

• Phase: PHASE4

Details

• Lead Sponsor: Emory University
• Collaborator: National Cancer Institute (NCI)
• Treatments: 4-fluorobenzoyl-Arg-Arg-Nal-Cys-Tyr-Cit-Lys-Lys-Pro-Tyr-Arg-Cit-Cys-Arg-NH2 (S-S bridged); 4-fluorobenzoyl-TN-14003; Acetaminophen; auricularum; BKT140; Blood Component Removal; Calcium Dobesilate; Dexamethasone; dexamethasone 21-phosphate; dexamethasone acetate; exifone; Famotidine; Loratadine; Medrol Veriderm; Methylprednisolone; montelukast; pegylated granulocyte colony-stimulating factor; Specimen Handling