RecruitingPhase 3NCT06514508

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

Sponsor

Guangzhou Gloria Biosciences Co., Ltd.

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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 Chinese patients with multiple myeloma.

Eligibility

Min Age: 18 YearsMax Age: 78 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called motixafortide (BL-8040) combined with G-CSF (a standard stem cell mobilization drug) can help multiple myeloma patients collect enough healthy stem cells for a transplant. Collecting enough stem cells is a critical step before high-dose chemotherapy and a stem cell transplant. **You may be eligible if...** - You are between 18 and 78 years old with a confirmed diagnosis of active multiple myeloma - You are eligible for an autologous stem cell transplant (using your own stem cells) - You are in complete remission (CR/sCR) or partial remission (PR/VGPR) after initial treatment - It has been at least 7 days since your last chemotherapy cycle - Your physical performance is good (ECOG 0-1) - Your organ function meets required thresholds **You may NOT be eligible if...** - You have already had a prior autologous or allogeneic stem cell transplant - You have active infection or significant heart disease - You are pregnant or breastfeeding - You have received more than 2 prior lines of therapy for myeloma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMotixafortide+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.

DRUGPlacebo+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.