NCT06514508

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou Gloria Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-31
• Completion: 2027-05-31
• First posted: 2024-07-23
• Last updated: 2025-12-16

Locations

2 sites across 1 country: China