Actively Recruiting
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
Led by Emory University · Updated on 2026-02-10
94
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be aged 18 years or older.
- Patient must understand and voluntarily sign an informed consent form.
- Patient must be willing and able to adhere to the study schedule and protocol requirements.
- Histologically confirmed multiple myeloma before enrollment and randomization.
- Eligible for hematopoietic stem cell mobilization and autologous hematopoietic stem cell transplantation per institutional guidelines.
- Females of reproductive potential must use effective contraception during motixafortide treatment and for 8 days after the final dose.
You will not qualify if you...
- Previous history of autologous or allogeneic hematopoietic cell transplantation.
- History of hemoglobin SS disease or hemoglobin S trait preventing use of G-CSF.
- History of steroid-induced psychosis or encephalopathy requiring medical intervention.
- History of poorly controlled type I or II diabetes mellitus or with high glucose variability that prevents safe dexamethasone 12mg IV premedication as judged by the investigator.
- History of serious systemic reaction to motixafortide.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
J
Joseph Rimando, MD
CONTACT
E
Edmund K. Waller, MD, PhD, FACP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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