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Chemokine Receptor Antagonist

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

Phase 3

Waitlist Available

Led By John DiPersio, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100 post-transplantation (± 7 days)

Awards & highlights

GENESIS 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.Check my eligibility

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.See study design

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.

GENESIS Trial 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.

GENESIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100 post-transplantation (± 7 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100 post-transplantation (± 7 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100 post-transplantation (± 7 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Percentage of Subjects Mobilizing ≥2 × 10^6 CD34+ Cells/kg in 1 Apheresis Session

Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg in 1 Apheresis Session

Subjects With Graft Durability at 100 Days Post Transplant/ Early Termination

+2 more

GENESIS 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioLineRx, Ltd.Lead Sponsor

21 Previous Clinical Trials

1,940 Total Patients Enrolled

1 Trials studying Multiple Myeloma

50 Patients Enrolled for Multiple Myeloma

John DiPersio, MDPrincipal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

53 Total Patients Enrolled

Crees Zachary, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

BL-8040 (Chemokine Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03246529 — Phase 3

Multiple Myeloma Research Study Groups: BL-8040 1.25 mg/kg + G-CSF, Placebo + G-CSF

Multiple Myeloma Clinical Trial 2023: BL-8040 Highlights & Side Effects. Trial Name: NCT03246529 — Phase 3

BL-8040 (Chemokine Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03246529 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant positions in this clinical trial for new patients?

"Unfortunately, this particular clinical trial is not looking for any more participants. Although, there are 1001 other trials that might be a match for you. This specific study was first posted on March 23rd, 2018 and updated on June 14th of 2022."

Answered by AI

How can I enroll in this research project?

"This clinical trial is recruiting 136 participants that currently suffer from multiple myeloma. The patients must be between 18-78 years old and meet the following additional requirements: have a histologically confirmed case of Multiple Myeloma, be at least 1 week out from their last induction cycle of chemotherapy, be eligible for an Autologous Hematopoietic stem cell transplantation, have an Eastern Cooperative Oncology Group performance status of 0 or 1, adequate organ function, and effective contraception."

Answered by AI

Does this research exclude people who are above a certain age?

"This trial is for patients aged 18-78. There are 117 clinical trials that cater to patients younger than this age bracket, and 922 for those older."

Answered by AI

What are some of the main diseases that BL-8040 1.25mg/kg + G-CSF has been known to help?

"BL-8040 1.25mg/kg + G-CSF can be used to treat febrile neutropenia, neutropenia, and infection."

Answered by AI

Could you please review prior research on BL-8040 1.25mg/kg + G-CSF?

"The first study into BL-8040 1.25mg/kg + G-CSF was done in 1997 at City of Hope Comprehensive Cancer Center. So far, 533 clinical trials have completed with 175 more active and ongoing studies. Many of these are based in Salt Lake City, Utah."

Answered by AI

Is it dangerous to take BL-8040 1.25mg/kg + G-CSF?

"BL-8040 1.25mg/kg + G-CSF has received a score of 3 from our Power team, which means that it is considered safe based on efficacy data from Phase 3 trials as well as supporting safety data from multiple rounds of testing."

Answered by AI

Where can I find a list of all the sites where this research is taking place?

"So far, this study has recruited 10 patients from locations such as the Huntsman Cancer Institute \ University of Utah in Salt Lake City, Mayo Clinic, Rochester in Rochester, and University of Cincinnati in Cincinnati."

Answered by AI

Recent research and studies

Future OncologyJournal

GENESIS: Phase III Trial Evaluating BL-8040 + G-CSF to Mobilize Hematopoietic Cells for Autologous Transplant in Myeloma

Crees, Zachary D, Keith Stockerl-Goldstein, Abi Vainstein, Hemda Chen, and John F DiPersio. 2019. “GENESIS: Phase III Trial Evaluating BL-8040 + G-CSF to Mobilize Hematopoietic Cells for Autologous Transplant in Myeloma”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2019-0380.

clinicaltrials.govStudy

A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous TransplantatIon in Subjects With MM

2018. "A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous TransplantatIon in Subjects With MM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03246529.

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