๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-23

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) (NCT03246529)

A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma - The GENESIS Study

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: BioLineRx, Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UCLA Medical Center โ€” Los Angeles, California

Age range: 18 Years to 78 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (18 Sites)

  • UCLA Medical Center โ€” Los Angeles, California
  • University of Florida โ€” Gainesville, Florida
  • University of Miami โ€” Miami, Florida
  • Loyola University Medical Center โ€” Chicago, Illinois
  • University of Maryland โ€” Baltimore, Maryland
  • Mayo Clinic โ€” Rochester, Minnesota
  • The Washington University School of Medicine โ€” St Louis, Missouri
  • University of Cincinnati โ€” Cincinnati, Ohio
  • MD Anderson Cancer Center โ€” Houston Texas, Texas
  • Huntsman Cancer Institute in University of Utah โ€” Salt Lake City, Utah
  • University of Koln โ€” Cologne, Koln
  • Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases โ€” Budapest,
  • University of Debrecen โ€” Debrecen,
  • Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele โ€” Catania,
  • Presidio Ospedaliero Morelli Viale Europa โ€” Reggio Calabria,
  • Hospital de La Santa Creu I Sant Pau โ€” Barcelona,
  • Hospital University Ramon y Cajal โ€” Madrid,
  • Hospital Universitario 12 de Octubre โ€” Madrid,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Multiple Myeloma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—