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

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

Interventions

DRUG

Acetaminophen

Given by mouth (PO).

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Dexamethasone

Given intravenously (IV).

OTHER

Electronic Health Record Review

Ancillary studies

DRUG

Famotidine

Given by mouth (PO).

DRUG

Loratadine

Given by mouth (PO).

DRUG

Methylprednisolone

Given intravenously (IV).

DRUG

Montelukast

Given by mouth (PO).

DRUG

Motixafortide

Given subcutaneously (SC).

PROCEDURE

Pheresis

Undergo apheresis

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Recombinant Granulocyte Colony-Stimulating Factor

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Gamida Cell ltd

  collaborator INDUSTRY

• Emory University

  lead OTHER

Principal Investigators

• Joseph Rimando, MD · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-24

Primary Completion

2026-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations