Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BL-8040/kg+ G-CSF · 1 trial · 1 indication
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...
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BL-8040 is an investigational small molecule being developed for the mobilization of hematopoietic stem cells to peripheral blood, as well as for acute myelogenous leukemia, multiple myeloma, aplastic anemia, and metastatic pancreatic adenocarcinoma. It is currently in clinical development and has not been approved by the FDA.
BL-8040 is a small molecule that targets the CXCR4 receptor, which plays a role in stem cell mobilization and cancer cell migration. By blocking this receptor, BL-8040 aims to release stem cells from the bone marrow into the bloodstream, which is useful for stem cell collection and potentially for enhancing the effects of other cancer therapies.
BL-8040 is being developed by BioLineRx Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BLRX. The company is conducting clinical trials to evaluate the safety and efficacy of BL-8040 in multiple indications, including stem cell mobilization and various cancers.
BL-8040 is in Phase 2 clinical development for several indications, including aplastic anemia and metastatic pancreatic adenocarcinoma. A Phase 3 trial for multiple myeloma is also active but not recruiting. BL-8040 is investigational and has not received FDA approval for any use.
BL-8040 has been studied in several clinical trials, including NCT02073019, a Phase 1 study in healthy volunteers for stem cell mobilization; NCT02462252, a Phase 2 study in aplastic anemia; NCT02826486, a Phase 2 study in metastatic pancreatic cancer; and NCT03246529, a Phase 3 study in multiple myeloma.
BL-8040 is also known as BL-8040 1.25 mg/kg + G-CSF, which refers to the combination of BL-8040 with granulocyte colony-stimulating factor (G-CSF) at a specific dose. This combination is being studied for stem cell mobilization, particularly in the context of autologous transplantation for multiple myeloma.