Multiple MyelomaPhase 1NCT06547112
A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization
A Phase 1 study testing Motixafortide and G-CSF in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Motixafortide and G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 19 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative serum pregnancy test at screening and negative urine or serum pregnancy test within 7 days prior to G-CSF first administration.
- Non-childbearing potential is defined as (by other than medical reasons):
- ≥45 years of age and has not had menses for over 2 years
- Post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation at least 6 weeks prior to screening
- Women of childbearing potential must agree to use 2 methods of effective contraception: One barrier method (e.g., diaphragm, or condom or sponge, each of which are to be combined with a spermicide) and one hormonal method, unless she uses a highly effective method. Highly effective methods of contraception include:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable, intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence These methods must be used starting at study enrollment and for the duration of study participation through 8 days after the last dose of motixafortide.
- Male subjects must agree to use an adequate method of contraception (barrier method) starting with the first day of G-CSF administration through 8 days after the last dose of motixafortide.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- 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
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- 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
- Received >6 cycles lifetime exposure to an IMiD
- Received >8 cycles of alkylating agent combinations
- Received >6 cycles of melphalan
- Received prior treatment with radioimmunotherapy (e.g., radionuclides, holmium)
- Received prior treatment with venetoclax
- Has received a live vaccine within 30 days of the planned start of G-CSF administration. Seasonal flu vaccines that do not contain live virus are permitted.
- Known active CNS metastases or carcinomatous meningitis
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to motixafortide, G-CSF or other agents used in the study
- Has an active or uncontrolled infection requiring systemic therapy
- Has a known additional malignancy that is progressing or requires active treatment
- Has a known underlying medical condition that, in the opinion of the treating physician or Principal Investigator, would preclude study participation.
- Is currently participating in an investigational treatment study, or has participated in a study of an investigational agent and received study therapy, or has been treated with an investigational device, within 4 weeks prior to the first dose of treatment.
- O2 saturation < 92% (on room air)
- Personal history or family history of long QT syndrome or torsade de pointes
- History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden cardiac death.
- History of myocardial infarction, CABG, coronary or cerebral artery stenting and/or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months prior to study enrollment, Angina Pectoris Class >2 or NYHA Heart Failure Class >2.
- ECG at screening showing QTcF >470 msec and/or PR >280 msec
- Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block, unless the participant has an implanted pacemaker or implantable cardiac defibrillator (ICD) with backup pacing capabilities.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating physician or Principal Investigator.
- Is pregnant or breast-feeding or expecting to conceive or women of childbearing potential unless consent to use two contraceptive methods or highly effective contraception as detailed above, within the projected duration of the trial, starting with the Screening Visit through 8 days after the last dose of study drug.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible.
- Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible.
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Motixafortide, G-CSF
- Keywords
- Hematopoietic stem cell mobilization, CXCR4 inhibition, Motixafortide, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotixafortideDrug
Also called BL-8040
Dose = 1.25 mg/kg via subcutaneous injection
G-CSFDrug
Dose = ~10 µg/kg (and maximum of 15 µg/kg) via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Motixafortide; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute number and relative proportions of CD34+ cell subsets by extended immunophenotypic profiling using multicolor fluorescence activated cell sorting (mFACS) on the apheresis product
Measured: From day 5 through day 8 (up to 4 days)
Secondary outcomes (16)
Number of participants with adverse events
Measured: From day 4 to end of study visit (estimated to be 15-26 days)
Change in concomitant medication use
Measured: From baseline through end of study visit (estimated to be 15-26 days)
Treatment compliance
Measured: From day 4 to end of study visit (estimated to be 15-26 days)
Number of participants who dropout due to adverse events
Measured: From day 4 to end of study visit (estimated to be 15-26 days)
Change in blood pressure
Measured: From baseline through end of study visit (estimated to be 15-26 days)
Change in temperature
Measured: From baseline through end of study visit (estimated to be 15-26 days)
Change in heart rate
Measured: From baseline through end of study visit (estimated to be 15-26 days)
Change in respiratory rate
Measured: From baseline through end of study visit (estimated to be 15-26 days)
Change in oxygen saturation at room air
Measured: From baseline through end of study visit (estimated to be 15-26 days)
Kinetics of PD assessed by the number of CD34+ cells/μL in peripheral blood
Measured: 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
Measured: At 12 hours in Cohort 1 and 16 hours in Cohort 2
Proportion of participants who mobilize ≥2.0 × 10^6 CD34+ cells/kg
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: In up to 1 apheresis session - from day 5 through day 8 (up to 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start31 Oct 2024
- Primary completion23 Jul 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- BioLineRx, Ltd., Arvrmid Pharma
- Responsible party
- Sponsor
- Investigators
- Zachary Crees, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547112
- Sponsor's protocol ID
- 202408102
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization
- ClinicalTrials.gov ID
- NCT06547112
- Acronym / sponsor ID
- 202408102
- Conditions
- Multiple Myeloma
- Keywords
- Hematopoietic stem cell mobilization, CXCR4 inhibition, Motixafortide, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- BioLineRx, Ltd., Arvrmid Pharma
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Standard dosing | Active comparator | Drug: Motixafortide, Drug: G-CSFFor 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. |
| Cohort 2: Early dosing | Experimental | Drug: Motixafortide, Drug: G-CSFFor 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. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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)
Key exclusion criteria (38 listed)
- 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:
- Received >6 cycles lifetime exposure to an IMiD
- Received >8 cycles of alkylating agent combinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MotixafortideAlso: BL-8040Dose = 1.25 mg/kg via subcutaneous injection | Drug | Cohort 1: Standard dosing, Cohort 2: Early dosing |
| G-CSFDose = ~10 µg/kg (and maximum of 15 µg/kg) via subcutaneous injection | Drug | Cohort 1: Standard dosing, Cohort 2: Early dosing |
Primary outcome
Absolute number and relative proportions of CD34+ cell subsets by extended immunophenotypic profiling using multicolor fluorescence activated cell sorting (mFACS) on the apheresis product
Time frame: From day 5 through day 8 (up to 4 days)
16 secondary outcomes
Number of participants with adverse events
Time frame: From day 4 to end of study visit (estimated to be 15-26 days)
Change in concomitant medication use
Time frame: From baseline through end of study visit (estimated to be 15-26 days)
Treatment compliance
Time frame: From day 4 to end of study visit (estimated to be 15-26 days)
Number of participants who dropout due to adverse events
Time frame: From day 4 to end of study visit (estimated to be 15-26 days)
Change in blood pressure
Time frame: From baseline through end of study visit (estimated to be 15-26 days)
Change in temperature
Time frame: From baseline through end of study visit (estimated to be 15-26 days)
Change in heart rate
Time frame: From baseline through end of study visit (estimated to be 15-26 days)
Change in respiratory rate
Time frame: From baseline through end of study visit (estimated to be 15-26 days)
Change in oxygen saturation at room air
Time frame: From baseline through end of study visit (estimated to be 15-26 days)
Kinetics of PD assessed by the number of CD34+ cells/μL in peripheral blood
Time frame: 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
Time frame: At 12 hours in Cohort 1 and 16 hours in Cohort 2
Proportion of participants who mobilize ≥2.0 × 10^6 CD34+ cells/kg
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: In up to 1 apheresis session - from day 5 through day 8 (up to 4 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Crees, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motixafortide and G-CSF in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute number and relative proportions of CD34+ cell subsets by extended immunophenotypic profiling using multicolor fluorescence activated cell sorting (mFACS) on the apheresis product (time frame: From day 5 through day 8 (up to 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.