Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients

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

Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients (NCT06514508) is a Phase 3 interventional studying Multiple Myeloma, sponsored by Guangzhou Gloria Biosciences Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Multiple Myeloma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - (Limit: 15,000 characters) 1. Patients must have a signed study willing to sign a consent form prior to entering the study. 2. Patients must be between the ages of 18 and 78 years. 3. Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria. 4. 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. 5. Eligible for Autologous Hematopoietic stem cell transplantation according to the Investigator's discretion. 6. The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR). 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 8. your organs (liver, kidneys, etc.) are working well enough based on blood tests at screening. 9. 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 Should NOT Join This Trial: 1. Previous history of autologous or allogeneic-HCT. 2. Failed previous HSC collections or collection attempts. 3. Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated waiting period after previous treatment: 1. Dexamethasone: 7 days 2. Thalidomide: 7 days 3. Lenalidomide: 7 days 4. Pamolidomide: 7 days 5. Bortezomib: 7 days 6. Carfilzomib: 7 days 7. G-CSF: 14 days 8. GM-CSF or Neulasta®: 21 days ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * (Limit: 15,000 characters) 1. Patients must have a signed study informed consent prior to entering the study. 2. Patients must be between the ages of 18 and 78 years. 3. Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria. 4. 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. 5. Eligible for Autologous Hematopoietic stem cell transplantation according to the Investigator's discretion. 6. The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR). 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 8. Adequate organ function at screening. 9. 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. Exclusion Criteria: 1. Previous history of autologous or allogeneic-HCT. 2. Failed previous HSC collections or collection attempts. 3. Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period: 1. Dexamethasone: 7 days 2. Thalidomide: 7 days 3. Lenalidomide: 7 days 4. Pamolidomide: 7 days 5. Bortezomib: 7 days 6. Carfilzomib: 7 days 7. G-CSF: 14 days 8. GM-CSF or Neulasta®: 21 days 9. Erythropoietin or erythrocyte stimulating agents: 30 days 10. Eltrombopag, romiplostim or platelet stimulating agents: 30 days 11. Carmustine (BCNU): 42 days/6 weeks 12. Daratumumab or any other anti-CD38: 28 days 13. Ixazomib: 7 day. 4. Received \>6 cycles lifetime exposure to thalidomide or lenalidomide. 5. Received \>8 cycles of alkylating agent combinations. 6. Received \> 6 cycles of melphalan. 7. Received prior treatment with radioimmunotherapy (e.g. radionuclides). 8. Received prior treatment with venetoclax. 9. Plans to receive maintenance treatment within 60 days post- transplantation (e.g.lenalidomide, bortezomib, pomalidomide, thalidomide, carfilzomib, etc.). 10. 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. 11. Known active CNS metastases or carcinomatous meningitis. 12. 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. 13. Has an active or uncontrolled infection requiring systemic therapy. 14. Has a known additional malignancy that is progressing or requires active treatment. 15. 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. 16. O2 saturation \< 92% (on room air). 17. Personal history or family history of Long QT Syndrome or Torsade de Pointes. 18. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden cardiac death. 19. 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. 20. ECG at screening showing QTcF \> 470 msec and/or PR \> 280 msec. 21. 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. 22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 23. 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. 24. 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). 25. 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.

Treatments Being Tested

DRUG

Motixafortide+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.

DRUG

Placebo+G-CSF

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.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University People's Hospital

Beijing, Beijing Municipality, China

Harbin The First Hospital

Harbin, Hei Longjiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06514508), the sponsor (Guangzhou Gloria Biosciences Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06514508 clinical trial studying?

Who can participate in NCT06514508?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06514508?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06514508. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06514508. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.