Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03246529 | A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) | PHASE3 | ACTIVE NOT_RECRUITING | 180 | — | — | Mar 23, 2018 | Sep 30, 2029 | Jan 15, 2026 | 18 | United States, Germany +3 |
Percentage of subjects mobilizing ≥6 × 10\^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous hematopoetic cell transplantation (auto-HCT) after treatment with G-CSF + single administration of BL-8040/placebo. Based on central laboratory data.
| Arm | Type | Description |
|---|---|---|
| BL-8040 1.25 mg/kg + G-CSF | EXPERIMENTAL | Double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM. |
| Placebo + G-CSF | ACTIVE_COMPARATOR | Double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM. |
| Name | Type | Description |
|---|---|---|
| BL-8040 1.25 mg/kg + G-CSF | DRUG | Up to 2 subcutaneous (SC) injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care |
| Placebo +G-CSF | DRUG | Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care |
Inclusion Criteria: 1. Histologically confirmed Multiple Myeloma prior to enrolment and randomization. 2. At least 1 week (7 days) from last induction cycle of combination/multi-agent cyto-reductive chemotherapy (e.g., KRD \[carfilzomib, lenalidomide, dexamethasone\] or VRD (e.g., bortezomib, lenal...