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PARADE Trial: Preventing Reactions to Motixafortide in Multiple Myeloma

This study, called the PARADE trial, is for people with multiple myeloma (a type of blood cancer) who are preparing for a stem cell transplant. To get enough stem cells, patients often receive a drug called motixafortide. However, motixafortide can cause allergic reactions at the injection site and throughout the body. This trial is comparing two different combinations of medications given before motixafortide to see which one better prevents these reactions. One combination includes dexamethasone, and the other uses methylprednisolone. Researchers will look at how often and how severe these reactions are on days 4 and 5. You may be able to join if you are 18 or older, have multiple myeloma, and are willing to follow the study plan. The current status of this study is unclear, and it plans to enroll 94 participants.

Study design
This interventional study is comparing two different premedication regimens in 94 participants. Patients will be randomly assigned to one of the two groups.
What's involved
You will have blood samples collected and your electronic health records reviewed. You will receive various medications by mouth and intravenously, and motixafortide by injection, followed by stem cell collection.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for reactions are measured on days 4 and 5.

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NCT07101445

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Emory University
~94 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:AcetaminophenBiospecimen CollectionDexamethasoneElectronic Health Record ReviewFamotidineLoratadine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of systemic reactions
Measured over At day 4 and 5
+1 more outcome measured

Conditions

Multiple Myeloma

Explore related trials

Multiple Myeloma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

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

Who to contact

Joseph Rimando, MD
[email protected]
404-778-1900
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence and severity of systemic reactionsAt day 4 and 5

    Will compare the incidence and severity of systemic reactions after administration of motixafortide. Systemic reactions will be graded as per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Analysis will be based upon an intent-to-treat analysis of all subjects who are randomized to receive dexamethasone or methylprednisolone. Will evaluate the proportion of patients who develop systemic reactions stratified by grade associated with motixafortide between the two premedication regimens. The non-inferiority probability (p)-value between the two arms will be carried out using one-sided z-test. In addition, these two groups will be compared at patient level using chi-square test or Fisher's Exact test. A logistic regression will be used to estimate the odd ratio between the two arms controlling for the baseline covariates for an improved precision of the estimation.

  • Incidence and severity of injection site reactionsAt day 4 and 5

    Will compare the incidence and severity of injection site reactions after administration of motixafortide. Injection site reactions will be graded as per CTCAE v5.0. The incidence of injection site reactions after administration of motixafortide between the two premedication regimens will be similarly compared to that of the incidence and severity of systemic reactions.