NCT06514508 Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients
| NCT ID | NCT06514508 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Guangzhou Gloria Biosciences Co., Ltd. |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria: * (Limit: 15,000 characters) 1. Patients must have a signed study informed consent prior to entering the study. 2. Patients must be between the ages of 18 and 78 years. 3. Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria. 4. 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. 5. Eligible for Autologous Hematopoietic stem cell transplantation according to the Investigator's discretion. 6. The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR). 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 8. Adequate organ function at screening. 9. Female subjects must be of non-childbearing pote