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

NCT06514508 | Recruiting Phase 3

• 1 other identifier: GLS-020-31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions

  Up to day 6

Secondary Outcomes (9)

• Proportion of patients who collect ≥2.0 × 10^6 CD34+ cells/kg in 1 apheresis session

  Up to Day 5

• Proportion of patients who collect ≥6.0 × 10^6 CD34+ cells/kg in 1 apheresis session

  Up to Day 5

• Number of CD34+ cells/kg collected

  Up to Day 8

• Maximum plasma concentration (Cmax)

  Up to Day 8

• Time from transplantation to neutrophil engraftment

  Up to post transplantation Day 29

Study Arms (2)

Motixafortide+G-CSF

EXPERIMENTAL

Drug: Motixafortide+G-CSF

Placebo+G-CSF

PLACEBO COMPARATOR

Drug: Placebo+G-CSF

Interventions

Motixafortide+G-CSF DRUG

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.

Also known as: BL-8040+G-CSF

Motixafortide+G-CSF

Placebo+G-CSF DRUG

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.

Placebo+G-CSF

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Guangzhou Gloria Biosciences Co., Ltd.: lead

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Harbin The First Hospital

Harbin, Hei Longjiang, 150010, China

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xiaojun Huang, M.D.

CONTACT

+86-13701389625; xjhrm@medmail.com.cn

Jun Ma, M.D.

CONTACT

+86-0451-84883471; majun0322@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 23, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (2)