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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

RecruitingPhase 4Ages 18 Years - anyAllEmory University
NCT07101445 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patie

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients must be aged 18 years or older. * Patient must understand and voluntarily signed an informed consent form. * Patient must be willing and able to adhere to the study schedule and other protocol requirements. * Histologically confirmed multiple myeloma prior to enrollment and randomization. * Eligible for hematopoietic stem cell mobilization and autologous hematopoietic stem cell transplantation as per institutional guidelines. * Females of reproductive potential must use effective contraception during treatment with motixafortide and for 8 days after the final dose. Exclusion Criteria: * Previous history of autologous or allogeneic hematopoietic cell transplantation. * History of hemoglobin SS disease or hemoglobin S trait precluding the patient's ability to use G-CSF. * History of steroid-induced psychosis or encephalopathy requiring medical intervention. * History of type I or II diabetes mellitus that is poorly controlled or with high glucose variability precluding safe administration of dexamethasone 12mg IV as premedication in the opinion of the investigator. * History of serious systemic reaction to motixafortide.
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What it tests

  • Acetaminophen
  • Biospecimen Collection
  • Dexamethasone
  • Electronic Health Record Review
  • Famotidine
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Where

1 site
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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