A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization
NCT Number: NCT06547112
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Multiple Myeloma
Interventions: DRUG: Motixafortide|DRUG: G-CSF
Sponsor: Washington University School of Medicine
Collaborators: BioLineRx, Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-31
Completion Date: 2026-01-31
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Number of participants with adverse events, From day 4 to end of study visit (estimated to be 15 days)|Change in concomitant medication use, From baseline through end of study visit (estimated to be 15 days)|Treatment compliance, From day 4 to end of study visit (estimated to be 15 days)|Number of participants who dropout due to adverse events, From day 4 to end of study visit (estimated to be 15 days)|Change in blood pressure, From baseline through end of study visit (estimated to be 15 days)|Change in temperature, From baseline through end of study visit (estimated to be 15 days)|Change in heart rate, From baseline through end of study visit (estimated to be 15 days)|Change in respiratory rate, From baseline through end of study visit (estimated to be 15 days)|Change in oxygen saturation at room air, From baseline through end of study visit (estimated to be 15 days)|Kinetics of PD assessed by the number of CD34+ cells/μL in peripheral blood, 0, +2, +4, +8, + 12 hours in Cohorts 1 and 2, +16 hours in Cohort 2, and, if needed +36 hours in Cohort 1 or +40 hours in Cohort 2|Apheresis yields assessed by total CD34+ cells/kg in apheresis product, At 12 hours in Cohort 1 and 16 hours in Cohort 2|Proportion of participants who mobilize ≥2.0 × 10^6 CD34+ cells/kg, In up to 2 apheresis sessions - from day 5 through day 8 (up to 4 days)|Proportion of participants who mobilize ≥5.0 × 10^6 CD34+ cells/kg, In up to 2 apheresis sessions - from day 5 through day 8 (up to 4 days)|Proportion of participants who mobilize ≥6.0 × 10^6 CD34+ cells/kg, In up to 2 apheresis sessions - from day 5 through day 8 (up to 4 days)|Proportion of participants who mobilize ≥2.0 × 10^6 CD34+ cells/kg, In up to 1 apheresis session - from day 5 through day 8 (up to 4 days)|Proportion of participants who mobilize ≥5.0 × 10^6 CD34+ cells/kg, In up to 1 apheresis session - from day 5 through day 8 (up to 4 days)