Multiple MyelomaPhase 3NCT06514508
Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients
A Phase 3 study testing Motixafortide+G-CSF in people with Multiple Myeloma, run by Guangzhou Gloria Biosciences Co., Ltd. at 2 sites in China.
Trial summary
This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in… 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+G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2025to 31 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- (Limit: 15,000 characters)
- Patients must have a signed study informed consent prior to entering the study.
- Patients must be between the ages of 18 and 78 years.
- Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria.
- At least one week (7 days) from last induction cycle of combination/multi-agent chemotherapy (e.g. KRD [carfilzomib, lenalidomide, dexamethasone] or VRD [bortezomib, lenalidomide, dexamethasone]) or from last single agent chemotherapy (e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc) prior to the first dose of G-CSF for mobilization.
- Eligible for Autologous Hematopoietic stem cell transplantation according to the Investigator's discretion.
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- The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function at screening.
- Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative serum pregnancy test at screening and negative serum pregnancy test within 72 hours prior to G-CSF first administration. Women of childbearing potential (WOCBP) and male subjects with WOCBP partners must agree to use highly effective contraception method during the study period and within 90 days after the last study treatment.
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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- Pamolidomide: 7 days
- Bortezomib: 7 days
- Carfilzomib: 7 days
- G-CSF: 14 days
- GM-CSF or Neulasta®: 21 days
- Erythropoietin or erythrocyte stimulating agents: 30 days
- Eltrombopag, romiplostim or platelet stimulating agents: 30 days
- Carmustine (BCNU): 42 days/6 weeks
- Daratumumab or any other anti-CD38: 28 days
- Ixazomib: 7 day.
- Received >6 cycles lifetime exposure to thalidomide or lenalidomide.
- Received >8 cycles of alkylating agent combinations.
- Received > 6 cycles of melphalan.
- Received prior treatment with radioimmunotherapy (e.g. radionuclides).
- Received prior treatment with venetoclax.
- Plans to receive maintenance treatment within 60 days post- transplantation (e.g.lenalidomide, bortezomib, pomalidomide, thalidomide, carfilzomib, etc.).
- 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.
- Is currently participating and/or receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of 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.
- Myocardial infarction, CABG, coronary or cerebral artery stenting and/or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months, 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 patient 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.
- 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, within the projected duration of the trial, starting with the Screening Visit through 90 days after the last dose of study drug.
- Known human immunodeficiency virus (HIV) or active Hepatitis B (e.g., Hepatitis B Surface Antigen [HBsAg] reactive and HBV DNA>500 IU/mL or >2500 copies/mL) or Hepatitis C (e.g., Hepatitis C Virus [HCV] RNA [qualitative] is positive).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaojun Huang, M.D., +86-13701389625, xjhrm@medmail.com.cn
- Not yet recruiting
Harbin The First Hospital
Harbin, Hei Longjiang, 150010
Jun Ma, M.D., +86-0451-84883471, majun0322@126.com
About this study
Official title: A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma
This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Motixafortide+G-CSF, Placebo+G-CSF
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motixafortide+G-CSFDrug
Also called BL-8040+G-CSF
Patients will receive the first dose of motixafortide (1.25 mg/kg) by subcutaneous (SC) injection on the evening of Day 4 (10 to 14 hours) prior to initiation of the first apheresis. A second dose of motixafortide can be administered 10 to 14 hours before a third apheresis, if necessary for patients who did not reach the goal of collection. Injections of G-CSF per standard of care.
Placebo+G-CSFDrug
Patients will receive the first dose of placebo by subcutaneous (SC) injection on the evening of Day 4 (10 to 14 hours) prior to initiation of the first apheresis. A second dose of placebo can be administered 10 to 14 hours before a third apheresis, if necessary for patients who did not reach the goal of collection. Injections of G-CSF per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Motixafortide+G-CSF | Experimental | Not described Receives: Drug: Motixafortide+G-CSF |
| Placebo+G-CSF | Placebo comparator | Not described Receives: Drug: Placebo+G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions
Measured: Up to day 6
Secondary outcomes (9)
Proportion of patients who collect ≥2.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Measured: Up to Day 5
Proportion of patients who collect ≥6.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Measured: Up to Day 5
Number of CD34+ cells/kg collected
Measured: Up to Day 8
Maximum plasma concentration (Cmax)
Measured: Up to Day 8
Time from transplantation to neutrophil engraftment
Measured: Up to post transplantation Day 29
Time from transplantation to platelets engraftment
Measured: Up to post transplantation Day 29
Graft durability at 100 days post-transplantation
Graft durability is defined as maintenance of at least 2 of the following 3 criteria:
- Platelet count ≥50 × 10^9/L without transfusion for at least 2 weeks.
- Hemoglobin level ≥10 g/dL with no erythropoietin support or transfusions for at least 1 month.
- Absolute neutrophil count (ANC) ≥1.0 × 10^9/L for 1 week.
Measured: Up to post transplantation Day 100
Change from Baseline in peripheral blood CD34+ cell concentration
Measured: Up to Day 8
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Day 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Dec 2025
- Primary completion11 Sep 2026
- Study completion31 May 2027 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Gloria Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514508
- Sponsor's protocol ID
- GLS-020-31
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06514508
- Acronym / sponsor ID
- GLS-020-31
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Gloria Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 11 Sep 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 23 Jul 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 is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motixafortide+G-CSF | Experimental | Drug: Motixafortide+G-CSF |
| Placebo+G-CSF | Placebo comparator | Drug: Placebo+G-CSF |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- (Limit: 15,000 characters)
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 thalidomide or lenalidomide.
- 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 |
|---|---|---|
| Motixafortide+G-CSFAlso: BL-8040+G-CSFPatients will receive the first dose of motixafortide (1.25 mg/kg) by subcutaneous (SC) injection on the evening of Day 4 (10 to 14 hours) prior to initiation of the first apheresis. A second dose of motixafortide can be administered 10 to 14 hours before a third apheresis, if necessary for patients who did not reach the goal of collection. Injections of G-CSF per standard of care. | Drug | Motixafortide+G-CSF |
| Placebo+G-CSFPatients will receive the first dose of placebo by subcutaneous (SC) injection on the evening of Day 4 (10 to 14 hours) prior to initiation of the first apheresis. A second dose of placebo can be administered 10 to 14 hours before a third apheresis, if necessary for patients who did not reach the goal of collection. Injections of G-CSF per standard of care. | Drug | Placebo+G-CSF |
Primary outcome
Proportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions
Time frame: Up to day 6
9 secondary outcomes
Proportion of patients who collect ≥2.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Time frame: Up to Day 5
Proportion of patients who collect ≥6.0 × 10^6 CD34+ cells/kg in 1 apheresis session
Time frame: Up to Day 5
Number of CD34+ cells/kg collected
Time frame: Up to Day 8
Maximum plasma concentration (Cmax)
Time frame: Up to Day 8
Time from transplantation to neutrophil engraftment
Time frame: Up to post transplantation Day 29
Time from transplantation to platelets engraftment
Time frame: Up to post transplantation Day 29
Graft durability at 100 days post-transplantation
Time frame: Up to post transplantation Day 100
Change from Baseline in peripheral blood CD34+ cell concentration
Time frame: Up to Day 8
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 38
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motixafortide+G-CSF in people with Multiple Myeloma, run by Guangzhou Gloria Biosciences Co., Ltd. at 2 sites in China.
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 10 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Huang, M.D. (+86-13701389625, xjhrm@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions (time frame: Up to day 6). 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 14 Sep 2026.