Synthetic peptide antagonist targeting CXCR4 · multiple myeloma Phase III clinical trial
Official protocol title:A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Study Evaluating Motixafortide (BL-8040) Combined with G-CSF for Mobilizing Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple Myeloma
Trial Summary
This study is a Phase III clinical trial jointly initiated by BioLineRx Ltd. and Guangzhou Gloria Biosciences Co., Ltd. It primarily targets patients with active multiple myeloma (MM) who have completed induction therapy (such as multidrug combination or monotherapy regimens containing carfilzomib, bortezomib, lenalidomide, or pomalidomide), are in first or second complete response (CR) or partial response, and are planned to undergo autologous peripheral blood hematopoietic stem cell transplantation. The treatment regimen compares the hematopoietic stem cell mobilizer (Motixafortide/BL-8040) combined with recombinant human granulocyte colony-stimulating factor (G-CSF) versus placebo combined with G-CSF. The dosing schedule consists of daily subcutaneous injections of G-CSF (for up to 8 consecutive days), with the first subcutaneous injection of Motixafortide or placebo administered 10 to 14 hours prior to each hematopoietic stem cell harvest (up to 2 doses). This study is conducted in China across a total of 12 leading domestic hematology hospitals and medical centers, including Harbin First Hospital, Peking University People's Hospital, Beijing Chaoyang Hospital of Capital Medical University, The First Affiliated Hospital of Sun Yat-sen University, and The First Affiliated Hospital of Zhejiang University School of Medicine.
Participating Centers0 in China + 12 overseas
Source and Verification
Every fact on this page is derived from the official study protocol document below. The source document is archived as a PDF for direct verification.
- Document type
- CDE clinical trial registration filing (original PDF)
- Official registration number
- CTR20242490
- Verify on the NMPA CDE public platformby entering CTR20242490 in the registration-number field. The platform is a search interface with no permanent per-study URL, so a direct link is not possible.
- Last reconciled
- 2026-09-07
Frequently Asked Questions about this Study
Structured facts derived from official protocol filings for patient and family reference
According to official protocol filings (target population synthesized by CMDN from study details, not an official CDE field), this study is primarily designed for patients with [Multiple myeloma]. Eligibility requires verified clinical confirmation by investigators regarding prior lines of therapy, active disease biomarkers, and performance status.
According to verified protocol filings, key eligibility thresholds include: age 18–78 years, ECOG performance status ≤ 1. The study specifies 9 inclusion and 25 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.
The core therapeutic target or investigational mechanism is [Synthetic peptide antagonist targeting CXCR4 (peptide drug)]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.
This study is registered as a [Phase III] clinical trial. The protocol is conducted under rigorous ethical and Good Clinical Practice (GCP) oversight approved by institutional ethics committees.
This is an international multi-centre study with 0 study centres in China and 12 overseas centres. The lead institution is [Hematologic Oncology Research Center of Harbin First Hospital]. Prominent sites include Hematologic Oncology Research Center of Harbin First Hospital, Peking University People's Hospital, Beijing Chaoyang Hospital, Capital Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20242490] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.
Key Information
Status
Recruiting
Phase
Phase III
Target / Therapy
Synthetic peptide antagonist targeting CXCR4 (peptide drug)
Sponsor
Guangzhou Gloria Biosciences Co., Ltd.
Principal Investigator
Jun Ma
Lead Institution
Hematologic Oncology Research Center of Harbin First Hospital
Participating Centers
0 in China + 12 overseas
CDE Registry ID
CTR20242490
ClinicalTrials.gov ID
NCT06514508Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
Keywords
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Protocol drugs and related tests are fully covered by the sponsor. All studies are strictly supervised by ethics committees, and patients retain the legal right to withdraw at any time.
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