NCT06547112

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Motixafortide	Dose = 1.25 mg/kg via subcutaneous injection
DRUG	G-CSF	Dose = \~10 µg/kg (and maximum of 15 µg/kg) via subcutaneous injection

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-07-23
• Completion: 2025-08-19
• First posted: 2024-08-09
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study