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NCT Number: 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 completing initial therapy (induction) when a stem cell transplant is not intended.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Gayathri Ravi, MD

SUB_INVESTIGATOR

Heidi Worth, MD

SUB_INVESTIGATOR

Kelly Godby, MD

SUB_INVESTIGATOR

Luciano J Costa, MD, PhD

CONTACT

[email protected]

Luciano J Costa, MD, PhD

SUB_INVESTIGATOR

Susan Bal, MD

CONTACT

[email protected]

2059347645

Susan Bal, MD

PRINCIPAL_INVESTIGATOR

About this study

This is an open-label study. The investigators propose to examine if BMS-986453 in people with newly diagnosed multiple myeloma may help control their disease for a prolonged period of time despite one-time treatment and challenge continuous treatment which is otherwise prescribed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years with no upper age limit
  • NDMM with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
  • Not eligible for ASCT by institutional criteria or deferring ASCT due to personal preference.
  • ECOG performance status 0-1
  • Adequate organ function

Exclusion criteria

  • Known active or history of central nervous system (CNS) involvement of MM.
  • Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS or clinically significant amiloidosis.
  • Prior history of other malignancies
  • Uncontrolled infection

Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986453

Drug

Will be given as a single dose administered by IV infusion.

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Baseline up to 5 years

    Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Baseline up to 5 years

    Measure of clinical response.

  2. Overall Survival (OS)

    Time frame: Baseline up to 5 years

    Measure of clinical response.

  3. Progression Free Survival (PFS)

    Time frame: Baseline up to 5 years

    Measure of clinical response.

  4. Pharmacokinetics (PK)

    Time frame: Baseline up to 2 years

    Measures of observed blood concentration of BMS-968453.

  5. Complete response rate

    Time frame: Baseline up to 5 years

    Measures of clinical response.

  6. MRD negativity

    Time frame: Baseline up to 5 years

    Proportion of participants with overall MRD negativity, 9-month MRD negativity rates as well as sustained (>12 months) MRD negativity.

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Up to 15 years

    Assess long-term toxicity

  8. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Up to 15 years

    Assess lentiviral vector safety

  9. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Up to 15 years

    Assess disease status

  10. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Up to 15 years

    Assess survival after BMS-968453 infusion

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret Thomas, MPH

CONTACT

[email protected]

Susan Bal, MD

CONTACT

[email protected]

(205) 934-7645

Sponsors and collaborators

Lead sponsor

Susan Bal

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma

Important dates

Study start
2026
Primary completion
2031
Study completion
2041
First posted
Jan 12, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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