Recruiting

Methylprednisolone vs. Dexamethasone

Sponsor:

Emory University

Code:

NCT07101445

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Biospecimen Collection

Dexamethasone

Electronic Health Record Review

Famotidine

Study Details

Brief 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. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patients and is considered the standard of care regimen for the prevention of systemic and injection site reactions 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. 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.

Conditions

Multiple Myeloma

Study ID

NCT07101445

Start date

Sep 24, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (Dexamethasone)

See Detailed Description

experimental: Arm II (Methylprednisolone)

See Detailed Description

Interventions

Acetaminophen

Given by mouth (PO).

Biospecimen Collection

Undergo blood sample collection

Dexamethasone

Given intravenously (IV).

Electronic Health Record Review

Ancillary studies

Famotidine

Given by mouth (PO).

Loratadine

Given by mouth (PO).

Methylprednisolone

Given intravenously (IV).

Montelukast

Given by mouth (PO).

Motixafortide

Given subcutaneously (SC).

Pheresis

Undergo apheresis

Questionnaire Administration

Ancillary studies

Recombinant Granulocyte Colony-Stimulating Factor

Give Granulocyte Colony-Stimulating Factor (G-CSF).

Primary outcome measure

  • Incidence and severity of systemic reactions [ Time Frame: At day 4 and 5 ]
  • Incidence and severity of injection site reactions [ Time Frame: At day 4 and 5 ]

Central Contacts and Locations

Central contacts

Joseph Rimando, MD

404-778-1900joseph.cataquiz.rimando@emory.edu

Edmund K. Waller, MD, PhD, FACP

404-778-1900ewaller@emory.edu

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Joseph Rimando, MD

404-778-8696jrimand@emory.edu

Principal Investigator:

Joseph Rimando, MD

More Information

Sponsor

Emory University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-23.