Comparing methylprednisolone versus dexamethasone premedication to prevent reactions to motixafortide during stem cell collection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase IV trial assigns patients to one of two premedication regimens given before a single subcutaneous dose of motixafortide used for stem cell mobilization. The standard regimen includes loratadine, famotidine, acetaminophen, montelukast, and dexamethasone 12 mg IV, while the experimental arm replaces dexamethasone with methylprednisolone 125 mg IV. All patients receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis starting the morning after motixafortide; additional apheresis days are allowed if CD34+ target is not met. Secondary aims compare tolerability and patient experience, effects on stem cell yield, and exploratory immunomodulatory differences between the regimens.

Why it matters

Who can join: the full rules

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.

Where it's running

• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Joseph Rimando, MD — Emory University Hospital/Winship Cancer Institute
• Study coordinator: Joseph Rimando, MD
• Email: joseph.cataquiz.rimando@emory.edu
• Phone: 404-778-1900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.