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Chemokine Receptor Antagonist

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

Phase 3

Waitlist Available

Led By Crees Zachary, MD

Research Sponsored by BioLineRx, Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subjects should be in first or second CR or PR

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Must not have

Known additional malignancy that is progressing or requires active treatment

Known history of HIV or active Hepatitis B or C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month post transplantation

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effectiveness and safety of G-CSF + BL-8040 to G-CSF + placebo in 207 subjects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions to components of BL-8040 or G-CSF; changes in blood counts; kidney, liver or coagulation problems; fatigue; infection risk due to immune system impact; heart-related issues like abnormal ECG readings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My condition is confirmed as Multiple Myeloma through testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that is getting worse or needs treatment.

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I have a history of HIV or active Hepatitis B or C.

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I have had a stem cell transplant using my own or a donor's cells.

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I or my family have a history of Long QT Syndrome or Torsade de Pointes.

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My previous attempts to collect stem cells were unsuccessful.

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I do not have an active or uncontrolled infection requiring treatment.

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I have active brain metastases or carcinomatous meningitis.

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I have received treatments like thalidomide or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month post transplantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month post transplantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month post transplantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions

Secondary study objectives

Graft Durability at 12 Months Post Transplantation

Graft Durability at 6 Months Post Transplantation

Graft Durability at 9 Months Post Transplantation

+5 more

Other study objectives

Annualized Relapse Rate Until September 2028

Overall Survival Until September 2028

Relapse Free Survival Until September 2028

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 12Eligibility criteria met