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

Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)

This trial tests whether replacing dexamethasone with methylprednisolone in a premedication mix better prevents systemic and injection-site reactions to motixafortide in adults with multiple myeloma who are collecting stem cells for transplant.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (other)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT07101445 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (18+) with histologically confirmed multiple myeloma who are eligible for autologous stem cell mobilization and transplantation and can give informed consent are the intended candidates.

Not a fit: Patients with prior autologous or allogeneic transplant, hemoglobin SS disease or trait preventing G-CSF use, uncontrolled diabetes, or a history of steroid-induced psychosis or other contraindications to the study steroids may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the methylprednisolone regimen could reduce allergic and injection-site reactions to motixafortide and make mobilization safer and more tolerable so more patients can proceed to autologous transplant.

How similar studies have performed: Motixafortide has previously improved stem cell collection rates and dexamethasone-based premedication is commonly used and reduces reactions, but a head-to-head comparison replacing dexamethasone with high-dose methylprednisolone for this indication is novel.

Eligibility criteria

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 this trial is running

Atlanta, Georgia

• 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

Conditions: Multiple Myeloma