drugset / Trial / NCT06547112
A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization
Phase 1
Completed
20 enrolled
Washington University School of Medicine
Arvrmid Pharma · collabBioLineRx, Ltd. · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2024-10-31
- Primary completion
- 2025-07-23
- Completion
- 2025-08-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Motixafortide | Peptide | 1.25 mg/kg | Subcutaneous |
| Background | G-CSF | Unknown | 10 ug/kg | Subcutaneous |