BL-8040 + G-CSF for Multiple Myeloma
(GENESIS Trial)

Recruiting in Palo Alto (17 mi)

+23 other locations

Overseen byCrees Zachary, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: BioLineRx, Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with Multiple Myeloma in first or second complete or partial remission, good performance status, and proper organ function. They must be eligible for stem cell transplant and not have had previous transplants, failed collections, certain medications recently, live vaccines within 30 days, active CNS metastases, other trials participation, serious health issues that could affect the trial's outcome or are pregnant/breastfeeding.

Inclusion Criteria

My cancer is responding to treatment and is in the first or second stage of partial or complete response.

I am fully active or restricted in physically strenuous activity but can do light work.

My blood, kidney, liver, and clotting tests are within normal ranges.

+5 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

Underlying medical condition that would preclude study participation

Your blood oxygen level is less than 92% when breathing normally.

+16 more

Participant Groups

The study compares the safety and effectiveness of a combination treatment using BL-8040 with G-CSF versus a placebo with G-CSF to mobilize hematopoietic stem cells for autologous transplantation in Multiple Myeloma patients. It's a double-blind study where neither participants nor researchers know who gets the real treatment until after results are collected.

2Treatment groups

Experimental Treatment

Active Control

Group I: BL-8040 1.25 mg/kg + G-CSFExperimental Treatment1 Intervention

Double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM.

Group II: Placebo + G-CSFActive Control1 Intervention

Double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM.