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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

March 23, 2018

Primary Completion Date

December 22, 2020

Study Completion Date

September 30, 2029

Conditions
Multiple Myeloma
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

Trial Locations (18)

1097

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

4032

University of Debrecen, Debrecen

21201

University of Maryland, Baltimore

28041

Hospital Universitario 12 de Octubre, Madrid

33136

University of Miami, Miami

45221

University of Cincinnati, Cincinnati

50923

University of Koln, Cologne

55902

Mayo Clinic, Rochester

60611

Loyola University Medical Center, Chicago

63110

The Washington University School of Medicine, St Louis

77030

MD Anderson Cancer Center, Houston

84112

Huntsman Cancer Institute in University of Utah, Salt Lake City

89133

Presidio Ospedaliero Morelli Viale Europa, Reggio Calabria

95124

Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele, Catania

100278

University of Florida, Gainesville

135250

Hospital University Ramon y Cajal, Madrid

167817

UCLA Medical Center, Los Angeles

08041

Hospital de La Santa Creu I Sant Pau, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioLineRx, Ltd.

INDUSTRY

NCT03246529 - 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) | Biotech Hunter | Biotech Hunter