IRB #

STUDY00017699

Title

A Phase III, Randomized, Double-Blinded, 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

Principal Investigator

Sarah Nagle

Study Purpose

This study is for patients with multiple myeloma who are undergoing autologous transplant. It compares two methods to increase the number of stem cells in the blood, which are collected from patients before their transplant. The study tries to find out if a study drug (BL-8040) added to usual care will help make more cells available for collection than the usual care with no study drug added. The study also tries to find out if the study drug combined with usual care will work faster than the usual care without the study drug.

Medical Condition(s)

Multiple Myeloma
Autologous bone marrow transplant

Eligibility Criteria

Basic inclusion:
-18-78 years of age
-Diagnosis of Multiple Myeloma
-Must be eligible for an autologous transplant
-At least 4 weeks from last chemotherapy treatment with combined drugs
-At least 7 days from last dose of chemotherapy given as a single drug
-Blood tests for blood, liver, and kidney activity must be adequate

Basic exclusion:
-No history of prior transplants
-A history of unsuccessful attempts at cell collection
-If you have had more than 6 chemotherapy cycles of Lenalidamide
-If you have had more than 2 chemotherapy cycles that are combinations that include alkylating agent drugs
-No prior radiation immunotherapy (radionuclides, holmium)
-Your disease can't have affected your central nervous system (CNS)
-You can't have recently participated in other investigational drug study
-If you have certain heart conditions
-If you or a family member has had a history of certain heart rhythm abnormalities
-If you have an active infection
-If you have a history of certain viral infections

Age Range

18 - 78

Healthy Volunteers Needed

No

Duration of Participation

Treatment is up to 8 days, long-term follow-up will be up to 5 years.

Minors Included

No

Contact

Knight Cancer Intake Center: (503)494-7999
Clinical Trials Information Line: (503)­494-­1080 or trials@ohsu.edu

Sponsor

BioLineRx, Ltd.

Recruitment End

12/01/2027

Compensation Provided

No


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