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Stem Cell Mobilizer

Cohort 2: Early dosing for Multiple Myeloma

Phase 1
Waitlist Available
Led By Zachary Crees, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 hours in cohort 1 and 16 hours in cohort 2
Awards & highlights

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.

Who is the study for?
This trial is for multiple myeloma patients who are undergoing standard quad-induction therapy. They will be part of a study to see how different timing of the drug motixafortide, combined with G-CSF, affects stem cell collection in their treatment.
What is being tested?
The study tests how well motixafortide works when given at 'standard' (~12 hours) vs 'early' (~16 hours) times before collecting stem cells. It also looks at the effects of quad-induction on stem cell types in the mobilized graft from these patients.
What are the potential side effects?
While specific side effects are not listed here, Motixafortide and G-CSF can generally cause bone pain, muscle aches, headaches, nausea and fatigue. The procedure may also have risks associated with apheresis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 hours in cohort 1 and 16 hours in cohort 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 hours in cohort 1 and 16 hours in cohort 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute number and relative proportions of CD34+ cell subsets by extended immunophenotypic profiling using multicolor fluorescence activated cell sorting (mFACS) on the apheresis product
Secondary study objectives
Apheresis yields assessed by total CD34+ cells/kg in apheresis product
Change in blood pressure
Change in concomitant medication use
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2: Early dosingExperimental Treatment2 Interventions
G-CSF daily in the morning for up to 8 days. Afternoon of Day 4 (2:00 to 4:00 PM), will receive motixafortide. Morning of Day 5, a 5th dose of G-CSF within 1 hour prior to apheresis. Undergo first apheresis \~16 hours after the motixafortide. If participant does not reach the collection goal for mobilization, on Day 6, a 6th dose of G-CSF will be administered prior to the 2nd apheresis session (\~40 hours from the first motixafortide injection). If participant doesn't reach the collection goal, a 2nd dose of motixafortide will be administered on the afternoon of Day 6 (2:00 to 4:00 PM). Morning of Day 7, a 7th dose of G-CSF will be administered within 1 hour prior to apheresis. Will then undergo 3rd apheresis \~16 hours after the 2nd motixafortide injection. If participant still does not reach the collection goal, a 4th apheresis will be performed on Day 8 , \~40 hours from the 2nd motixafortide injection, with an 8th dose of G-CSF administered prior to the apheresis.
Group II: Cohort 1: Standard dosingActive Control2 Interventions
G-CSF daily in the morning for up to 8 days. Evening of Day 4 (6:00 to 8:00 PM), will receive motixafortide. Morning of Day 5, a 5th dose of G-CSF within 1 hour prior to apheresis. Undergo first apheresis \~12 hours after the motixafortide. If participant does not reach the collection goal for mobilization, on Day 6, a 6th dose of G-CSF will be administered prior to the 2nd apheresis session (\~36 hours from the first motixafortide injection). If participant doesn't reach the collection goal, a 2nd dose of motixafortide will be administered on the evening of Day 6 (6:00 to 8:00 PM). Morning of Day 7, a 7th dose of G-CSF will be administered within 1 hour prior to apheresis. Will then undergo 3rd apheresis \~12 hours after the 2nd motixafortide injection. If participant still does not reach the collection goal, a 4th apheresis will be performed on Day 8 , \~36 hours from the 2nd motixafortide injection, with an 8th dose of G-CSF administered prior to the apheresis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
G-CSF
2014
Completed Phase 4
~1610

Find a Location

Who is running the clinical trial?

BioLineRx, Ltd.Industry Sponsor
23 Previous Clinical Trials
2,140 Total Patients Enrolled
2 Trials studying Multiple Myeloma
230 Patients Enrolled for Multiple Myeloma
Washington University School of MedicineLead Sponsor
1,962 Previous Clinical Trials
2,312,642 Total Patients Enrolled
33 Trials studying Multiple Myeloma
2,247 Patients Enrolled for Multiple Myeloma
Zachary Crees, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
10 Total Patients Enrolled
~13 spots leftby Jan 2026
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