Phase III Study on the Safety and Effectiveness of BL-8040 and G-CSF for Stem Cell Mobilization in Multiple Myeloma Patients

Sponsor: BioLineRx, Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT03246529

This clinical trial is testing a new combination treatment using BL-8040 and G-CSF to help mobilize stem cells for transplantation in patients with Multiple Myeloma. The study compares this new treatment to a placebo with G-CSF to see which is more effective and safe.

Patient Parameters

Parameter	Options

Program Overview

The study involves 122 participants who are randomly assigned to receive either the combination of BL-8040 and G-CSF or a placebo with G-CSF. The goal is to evaluate how well the combination treatment works and how safe it is for patients with Multiple Myeloma who need stem cell transplantation.

Description

The study is conducted in two parts:

Part 1: This initial phase involved 12 participants to determine the best dose of BL-8040. Participants received open-label treatment with G-CSF and BL-8040 to assess how well the treatment mobilizes stem cells, as well as its safety and how the body processes the drug.
Part 2: After Part 1, 122 participants were randomly assigned to receive either the combination of BL-8040 and G-CSF or a placebo with G-CSF. This phase is double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo. The aim is to compare the effectiveness and safety of the two treatments.

Eligibility Criteria

Inclusion Criteria

Diagnosed with Multiple Myeloma before joining the study.
At least one week since the last chemotherapy treatment before starting G-CSF.
Eligible for stem cell transplantation as determined by the doctor.
Currently in complete or partial remission.
Good overall health with a performance status of 0 or 1.
Adequate organ function, including:
- Sufficient white blood cell and neutrophil counts.
- Platelet count above 100,000.
- Kidney function with a GFR of at least 15.
- Liver function with ALT/AST levels within specified limits.
- Normal blood clotting times unless on anticoagulants.
Male participants must use contraception during and after treatment.
Signed informed consent to participate in the study.

Exclusion Criteria

Previous stem cell transplantation.
Failed previous attempts to collect stem cells.
Recent use of certain medications or treatments within specified timeframes before starting G-CSF.
Extensive prior treatment with certain chemotherapy drugs.
Previous radioimmunotherapy or treatment with venetoclax.
Plans for maintenance treatment soon after transplantation.
Recent live vaccination.
Active brain metastases or cancer in the brain lining.
Allergies to study drugs or similar compounds.
Active infections requiring treatment.
Additional progressing cancer requiring treatment.
Medical conditions that would interfere with the study.
Participation in another study or treatment with investigational drugs recently.
Low oxygen levels.
Heart conditions or history of heart-related issues.
Abnormal ECG results.
Certain types of heart block without a pacemaker.
Conditions or treatments that could affect study results.
Psychiatric or substance abuse issues affecting study participation.
Pregnant or breastfeeding women.
History of HIV or active Hepatitis B or C infections.

Locations

FACILITY	ZIP	CITY	STATE
UCLA Medical Center	167817	Los Angeles	California
University of Florida	100278	Gainesville	Florida
University of Miami	33136	Miami	Florida
Loyola University Medical Center	60611	Chicago	Illinois
University of Maryland	21201	Baltimore	Maryland
Mayo Clinic	55902	Rochester	Minnesota
The Washington University School of Medicine	63110	St Louis	Missouri
University of Cincinnati	45221	Cincinnati	Ohio
MD Anderson Cancer Center	77030	Houston Texas	Texas
Huntsman Cancer Institute in University of Utah	84112	Salt Lake City	Utah

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