BMS-986453 for Multiple Myeloma

Overseen By Margaret Thomas, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Susan Bal

Disqualifiers: CNS involvement, Plasma cell leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986453 for people with multiple myeloma, a type of blood cancer, who have just completed their first round of therapy. The study aims to determine the treatment's safety and effectiveness, particularly for those not planning a stem cell transplant. Participants will receive a single dose of the treatment after receiving other medicines through an IV for three days. It suits individuals diagnosed with multiple myeloma within the last year who have completed initial therapy and are not considering a stem cell transplant. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that BMS-986453 is likely to be safe for humans?

Research has shown that BMS-986453 is being tested for safety in treating multiple myeloma, a type of blood cancer. In earlier studies, researchers administered BMS-986453 to individuals whose multiple myeloma returned or didn't respond to treatment. These studies focus on how well participants tolerate the treatment and any side effects over time.

Although specific results from these studies aren't shared here, testing BMS-986453 in humans suggests that earlier lab or animal tests indicated it was safe enough to proceed. However, since this is an early phase trial, researchers continue to collect detailed safety information.

For those considering joining a trial, it's important to know that the main goal is to understand the treatment's safety and its effects on the body. Researchers will closely monitor participants' health and any side effects during the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BMS-986453 is unique because it introduces a new approach to treating multiple myeloma. Unlike traditional therapies that often rely on proteasome inhibitors and immunomodulatory drugs, BMS-986453 works by targeting specific pathways in the cancer cells. Researchers are excited about this treatment because it offers a novel mechanism of action that could potentially enhance effectiveness and reduce side effects compared to existing options. Additionally, its use in combination with fludarabine and cyclophosphamide might improve outcomes for patients who have not responded well to standard treatments.

What evidence suggests that BMS-986453 might be an effective treatment for multiple myeloma?

Research has shown that BMS-986453 might help treat multiple myeloma. In earlier studies, 88% of patients experienced a reduction or halt in cancer growth, and 45% had no detectable signs of cancer after treatment. These results suggest that BMS-986453 could effectively manage multiple myeloma. However, a serious side effect occurred, with one patient dying from a drug-related cause. This underscores the need for further research to confirm its safety and effectiveness. Participants in this trial will receive a single dose of BMS-986453, administered by IV infusion, following treatment with fludarabine and cyclophosphamide. ^{1 2 4 5 6}

Who Is on the Research Team?

Susan Bal, MD

Principal Investigator

The University of Alabama at Birmingham

Luciano A Costa, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with newly diagnosed multiple myeloma who have finished their first round of therapy and are not planning to undergo a stem cell transplant. Specific eligibility details are not provided, but typically include factors like age, overall health status, and the specifics of their cancer diagnosis.

Inclusion Criteria

I am not eligible for or am choosing not to have a stem cell transplant.

I am over 18 years old.

I am fully active or can carry out light work.

Exclusion Criteria

My multiple myeloma has affected or previously affected my brain or spinal cord.

I have been diagnosed with a specific blood disorder.

I have had cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive fludarabine and cyclophosphamide for 3 days prior to BMS-986453 infusion

1 week

Treatment

A single dose of BMS-986453 administered by IV infusion

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Long-term follow-up

Participants are assessed for long-term survival and adverse events

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986453

Trial Overview

The study is testing BMS-986453 in patients with new multiple myeloma after initial treatment. It's a phase 1b trial focused on assessing the safety and effectiveness of this drug when a stem cell transplant isn't part of the patient's treatment plan.

How Is the Trial Designed?

Group I: Single dose BMS-986453 Experimental Treatment 1 Intervention

Participants will be treated with fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day) for 3 days prior to BMS-986453 infusion. A single dose of BMS-986453 administered by IV infusion.

Who Is Running the Clinical Trial?

Susan Bal

Lead Sponsor

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07333261

Study of BMS-986453 in Newly Diagnosed Multiple Myeloma

This is a phase 1b study evaluating if BMS-986453 is safe and effective in treating people who have newly diagnosed multiple myeloma after ...

2.

oncologypipeline.com

oncologypipeline.com/apexonco/bristol-makes-quick-pivotal-move-multiple-myeloma

Bristol makes a quick pivotal move in multiple myeloma

In phase 1 BMS-986393 yielded an 88% ORR and 45% CR rate – better than Talvey on a cross-trial basis – though one patient died from drug-related ...

3.

mountsinai.org

mountsinai.org/clinical-trials/study-to-assess-bms-986453-in-participants-with-relapsed-refractory-multiple-myeloma

A Study to Assess BMS-986453 in Participants With ...

Summary: The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM). Eligibility:

4.

moffitt.org

moffitt.org/clinical-trials-and-studies/clinical-trial-23203/

Clinical Trial 23203

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM). Objective: Primary: To evaluate the ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06153251

NCT06153251 | A Study to Assess BMS-986453 in ...

Study Overview​​ The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

6.

clin.larvol.com

clin.larvol.com/trial-detail/NCT07333261

Study of BMS-986453 in Newly Diagnosed Multiple Myeloma

Evaluate the safety and tolerability of BMS-986453 in participants with NDMM. Baseline up to 5 years. Secondary. Outcome Measure, Measure Description, Time ...