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)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
180actual
Sites
18
Countries
Germany, Hungary, Italy +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-03-23 | actual | When the study began enrolling |
| Primary completion | 2020-12-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2017-08-11 | actual | When this record first appeared on the registry |
| Results posted | 2023-11-07 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Multiple Myeloma
Interventions
- Drug: BL-8040 1.25 mg/kg + G-CSF
- Drug: Placebo +G-CSF
Primary outcome
what the primary-completion date above is the date OFPercentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions
measured From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2020-04-21 · 3.5 MB · Prot_SAP_000.pdf
Publications
- PMID 37069359 — linked by the registry
- PMID 31495201 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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