A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization

NCT06547112 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 202408102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study includes extended CD34+ profiling on the apheresis product of multiple myeloma patients undergoing standard-of-care quad-induction followed by motixafortide + G-CSF mobilization, and in addition, assesses the pharmacodynamics (PD) of motixafortide following "standard" (\~12 hours) vs "early" (\~16 hours) dosing. The investigators hypothesize that quad-induction may alter the stem cell subsets within the mobilized graft. The investigators further hypothesize that standard and early dosing strategies will result in comparable mobilization and stem cell collection rates.

Conditions

Multiple Myeloma

Keywords

Hematopoietic stem cell mobilization; CXCR4 inhibition; Motixafortide; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Absolute number and relative proportions of CD34+ cell subsets by extended immunophenotypic profiling using multicolor fluorescence activated cell sorting (mFACS) on the apheresis product

  From day 5 through day 8 (up to 4 days)

Secondary Outcomes (16)

• Number of participants with adverse events

  From day 4 to end of study visit (estimated to be 15-26 days)

• Change in concomitant medication use

  From baseline through end of study visit (estimated to be 15-26 days)

• Treatment compliance

  From day 4 to end of study visit (estimated to be 15-26 days)

• Number of participants who dropout due to adverse events

  From day 4 to end of study visit (estimated to be 15-26 days)

• Change in blood pressure

  From baseline through end of study visit (estimated to be 15-26 days)

Study Arms (2)

Cohort 1: Standard dosing

ACTIVE COMPARATOR

For Cohort 1, motixafortide will be given on Day 4 between 6:00 and 8:00 pm. A second dose may be given on Day 6 between 6:00 and 8:00 p.m. if CD34+ cell collection goals are not met on Day 5 apheresis.

Drug: Motixafortide; Drug: G-CSF

Cohort 2: Early dosing

EXPERIMENTAL

For Cohort 2, motixafortide will be given on Day 4 between 2:00 and 4:00 pm. A second dose may be given on Day 6 with goal of administration between 6:00 and 8:00 pm after completion of pheresis if clinically feasible. if CD34+ cell collection goals are not met on Day 5 apheresis.

Drug: Motixafortide; Drug: G-CSF

Interventions

Motixafortide DRUG

Dose = 1.25 mg/kg via subcutaneous injection

Also known as: BL-8040

Cohort 1: Standard dosing; Cohort 2: Early dosing

G-CSF DRUG

Dose = \~10 µg/kg (and maximum of 15 µg/kg) via subcutaneous injection

Cohort 1: Standard dosing; Cohort 2: Early dosing

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be between the ages of 18 and 78 years, inclusive.
• Histologically confirmed multiple myeloma expected to receive high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT)
• Received ≥3 cycles but ≤6 cycles of daratumumab-based quadruplet induction therapy (quadruplet induction therapy: combining daratumumab, a proteasome inhibitor, an IMiD, and dexamethasone) before ASCT
• At least one week (7 days) from last induction cycle prior to the first dose of G-CSF for mobilization
• The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR)
• ECOG performance status 0 or 1
• Adequate organ function at screening as defined below:
• White blood cell (WBC) counts \> 2.5 × 10\^9/L
• Absolute neutrophil count \> 1.5 K/cumm
• Platelet count \>100 K/cumm
• GFR value of ≥15 mL/min/1.732 (by MDRD equation)
• ALT and/or AST ≤2.5 × ULN
• Total bilirubin ≤2.0 × ULN unless the participant has Gilbert disease
• INR or PT: ≤1.5 × ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
• aPTT: ≤1.5 × ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants.

You may not qualify if:

• Previous history of autologous or allogeneic-HCT
• Failed previous HSC collections or collection attempts
• Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period:
• Dexamethasone: 7 days
• Thalidomide: 7 days
• Lenalidomide: 7 days
• Pomalidomide: 7 days
• Bortezomib: 7 days
• Carfilzomib: 7 days
• Ixazomib: 7 days
• G-CSF: 14 days
• GM-CSF or pegfilgrastim: 21 days
• Erythropoietin or erythrocyte-stimulating agents: 30 days
• Eltrombopag, romiplostim or platelet-stimulating agents: 30 days
• Carmustine (BCNU): 42 days/6 weeks

Sponsors & Collaborators

• Washington University School of Medicine: lead
• BioLineRx, Ltd.: collaborator
• Arvrmid Pharma: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Multiple Myeloma

Interventions

4-fluorobenzoyl-TN-14003; 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)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Zachary Crees, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will comprise 2 cohorts enrolled sequentially, each with 10 subjects. The first 10 patients will be enrolled to Cohort 1, and the next 10 patients will be enrolled to Cohort 2.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: October 31, 2024
• Primary Completion: July 23, 2025
• Study Completion: August 19, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)