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

NCT07101445 | Recruiting Phase 4 DMC FDA Drug

• 4 other identifiers: STUDY00008909NCI-2025-03018WINSHIP6478-24P30CA138292
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of systemic reactions

  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.

  At day 4 and 5

• Incidence and severity of injection site reactions

  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.

  At day 4 and 5

Secondary Outcomes (4)

• Compare Tolerability Between Regimens

  At days 4 and 5

• CD34+ hematopoietic stem and progenitor cells (HSPC)/kg collection

  Up to day 8

• Collection of >= 6 x 10^6 CD34+ HSPC/kg

  At day 5

• Cytokine levels

  At days 4 and 5

Study Arms (2)

Arm I (Dexamethasone)

ACTIVE COMPARATOR

See Detailed Description

Drug: Acetaminophen; Procedure: Biospecimen Collection; Drug: Dexamethasone; Other: Electronic Health Record Review; Drug: Famotidine; Drug: Loratadine; Drug: Montelukast; Drug: Motixafortide; Procedure: Pheresis; Other: Questionnaire Administration; Biological: Recombinant Granulocyte Colony-Stimulating Factor

Arm II (Methylprednisolone)

EXPERIMENTAL

See Detailed Description

Drug: Acetaminophen; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Famotidine; Drug: Loratadine; Drug: Methylprednisolone; Drug: Montelukast; Drug: Motixafortide; Procedure: Pheresis; Other: Questionnaire Administration; Biological: Recombinant Granulocyte Colony-Stimulating Factor

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Acetaminophen DRUG

Given by mouth (PO).

Also known as: Acetaminophen (APAP), Paracetamol, Tylenol

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Dexamethasone DRUG

Given intravenously (IV).

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Arm I (Dexamethasone)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Famotidine DRUG

Given by mouth (PO).

Also known as: Pepcid, Pepcid AC

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Loratadine DRUG

Given by mouth (PO).

Also known as: Claritin

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Methylprednisolone DRUG

Given intravenously (IV).

Also known as: Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone, Firmacort, Medlone 21, Medrate, Medrol, Medrol Veriderm, Medrone, Mega-Star, Meprolone, Methylprednisolonum, Metilbetasone Solubile, Metrocort, Metypresol, Metysolon, Predni-M-Tablinen, Prednilen, Radilem, Sieropresol, Solpredone, Summicort, Urbason, Veriderm Medrol, Wyacort

Arm II (Methylprednisolone)

Montelukast DRUG

Given by mouth (PO).

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Motixafortide DRUG

Given subcutaneously (SC).

Also known as: 4F-Benzoyl-TN14003, BKT 140, BKT-140, BKT140, BL 8040, BL-8040, BL8040, TF 14016, TF-14016, TF14016

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Pheresis PROCEDURE

Undergo apheresis

Also known as: Apheresed, Apheresis, Blood Component Removal, Collection, Apheresis/Leukapheresis, Hemapheresis

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Recombinant Granulocyte Colony-Stimulating Factor BIOLOGICAL

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

Also known as: Recombinant Colony-Stimulating Factor 3, rhG-CSF

Arm I (Dexamethasone); Arm II (Methylprednisolone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gamida Cell ltd: collaborator
• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Acetaminophen; Specimen Handling; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Famotidine; Loratadine; Methylprednisolone; exifone; Medrol Veriderm; montelukast; 4-fluorobenzoyl-TN-14003; BKT140; 4-fluorobenzoyl-Arg-Arg-Nal-Cys-Tyr-Cit-Lys-Lys-Pro-Tyr-Arg-Cit-Cys-Arg-NH2 (S-S bridged); Blood Component Removal; pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Piperidines; Prednisolone; Therapeutics

Study Officials

• Joseph Rimando, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Rimando, MD

CONTACT

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

Edmund K. Waller, MD, PhD, FACP

CONTACT

404-778-1900; ewaller@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The labels of the medications will be masked to the patient, the investigator, and the treating nurse.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)