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RECRUITING
NCT06514508
PHASE3

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

Sponsor: Guangzhou Gloria Biosciences Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 78 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12-01

Completion Date

2027-05-31

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

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)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Harbin The First Hospital

Harbin, Hei Longjiang, China