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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07101445
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acetaminophen — DRUG
    Given by mouth (PO).
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Dexamethasone — DRUG
    Given intravenously (IV).
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Famotidine — DRUG
    Given by mouth (PO).
  • Loratadine — DRUG
    Given by mouth (PO).
  • Methylprednisolone — DRUG
    Given intravenously (IV).
  • Montelukast — DRUG
    Given by mouth (PO).
  • Motixafortide — DRUG
    Given subcutaneously (SC).
  • Pheresis — PROCEDURE
    Undergo apheresis
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Recombinant Granulocyte Colony-Stimulating Factor — BIOLOGICAL
    Give Granulocyte Colony-Stimulating Factor (G-CSF).

Study Details

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.

Key Dates

Start date
Sep 24, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm I (Dexamethasone)
    See Detailed Description
  • Experimental: Arm II (Methylprednisolone)
    See Detailed Description

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Joseph Rimando, MD
[email protected]
404-778-8696
Joseph Rimando, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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