Actively Recruiting
Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients
Led by Guangzhou Gloria Biosciences Co., Ltd. · Updated on 2025-12-16
60
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to study entry
- Aged between 18 and 78 years
- Diagnosis of active multiple myeloma as defined by IMWG criteria
- At least 7 days since last chemotherapy before first G-CSF dose for mobilization
- Eligible for autologous hematopoietic stem cell transplantation
- In first or second complete or partial remission, including stringent complete remission and very good partial remission
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate organ function at screening
- Female participants of childbearing potential must have negative pregnancy tests and agree to use effective contraception during the study and for 90 days after last treatment
You will not qualify if you...
- Previous autologous or allogeneic hematopoietic stem cell transplantation
- Prior failed stem cell collections or attempts
- Use of specified medications or growth factors within defined washout periods before study treatment
- More than 6 cycles lifetime exposure to thalidomide or lenalidomide
- More than 8 cycles of alkylating agent combinations
- More than 6 cycles of melphalan
- Prior treatment with radioimmunotherapy or venetoclax
- Planned maintenance treatment within 60 days post-transplant
- Live vaccine within 30 days before G-CSF administration (except seasonal flu vaccines without live virus)
- Active central nervous system metastases or carcinomatous meningitis
- Allergic reactions to study drugs or similar compounds
- Active or uncontrolled infection requiring systemic therapy
- Additional progressing malignancy requiring treatment
- Participation in other investigational studies within 4 weeks prior to treatment
- Oxygen saturation below 92% on room air
- Personal or family history of Long QT Syndrome, Torsade de Pointes, unexplained syncope, or sudden cardiac death
- Recent serious cardiac events or significant heart conditions
- Abnormal ECG findings including prolonged QTcF or PR intervals
- Certain heart blocks unless pacemaker or ICD in place
- Psychiatric or substance abuse disorders interfering with study compliance
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Known HIV or active Hepatitis B or C infections
- Any condition or therapy that could interfere with participation or study results as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Harbin The First Hospital
Harbin, Hei Longjiang, China, 150010
Not Yet Recruiting
Research Team
X
Xiaojun Huang, M.D.
CONTACT
J
Jun Ma, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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