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NCT03246529 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Multiple Myeloma, sponsored by BioLineRx.
- Active
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 18
- Study locations
NCT03246529: Active Phase 3 study of Multiple Myeloma, sponsored by BioLineRx.
NCT03246529 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by BioLineRx. The registered enrollment target is 180 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (67% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03246529, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by BioLineRx.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 18
- Study locations
Study Summary
A total of 122 subjects were randomized into the study and investigated in the double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG BL-8040 1.25 mg/kg + G-CSF
- DRUG Placebo +G-CSF
Study Locations (18)
Other
- Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases - Budapest
- University of Debrecen - Debrecen
- Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele - Catania
- Presidio Ospedaliero Morelli Viale Europa - Reggio Calabria
- Hospital de La Santa Creu I Sant Pau - Barcelona
- Hospital University Ramon y Cajal - Madrid
- Hospital Universitario 12 de Octubre - Madrid
Florida
- University of Florida - Gainesville
- University of Miami - Miami
California
- UCLA Medical Center - Los Angeles
Illinois
- Loyola University Medical Center - Chicago
Maryland
- University of Maryland - Baltimore
Minnesota
- Mayo Clinic - Rochester
Missouri
- The Washington University School of Medicine - St Louis
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2029-09-30 |
| Phase | Phase 3 |
What the registry record for NCT03246529 still lists
NCT03246529 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which BL-8040 1.25 mg/kg + G-CSF is the first listed.
NCT03246529 lists 18 locations in 11 states (Other, Florida, California).
Frequently Asked Questions
What is clinical trial NCT03246529 about?
NCT03246529 is a clinical study titled "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)". A total of 122 subjects were randomized into the study and investigated in the double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
What is the current status of trial NCT03246529?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2018-03-23. Estimated completion is 2029-09-30.
What conditions does trial NCT03246529 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03246529?
The interventions under investigation include: BL-8040 1.25 mg/kg + G-CSF (DRUG), Placebo +G-CSF (DRUG).
Who is sponsoring clinical trial NCT03246529?
This trial is sponsored by BioLineRx, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03246529 being conducted?
This trial has 18 study locations across California, Florida, Illinois, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03246529's enrollment target sits among peer trials
180 119th of 438 higher than 318 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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