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ACTIVE NOT RECRUITING
NCT03246529
PHASE3

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)

Sponsor: BioLineRx, Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 78 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2018-03-23

Completion Date

2029-09-30

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DRUG

BL-8040 1.25 mg/kg + G-CSF

Up to 2 subcutaneous (SC) injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care

DRUG

Placebo +G-CSF

Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care

Locations (18)

UCLA Medical Center

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Loyola University Medical Center

Chicago, Illinois, United States

University of Maryland

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

The Washington University School of Medicine

St Louis, Missouri, United States

University of Cincinnati

Cincinnati, Ohio, United States

MD Anderson Cancer Center

Houston Texas, Texas, United States

Huntsman Cancer Institute in University of Utah

Salt Lake City, Utah, United States

University of Koln

Cologne, Koln, Germany

Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases

Budapest, Hungary

University of Debrecen

Debrecen, Hungary

Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele

Catania, Italy

Presidio Ospedaliero Morelli Viale Europa

Reggio Calabria, Italy

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Hospital University Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain