Recruiting
Phase 1

BMS-986453

Sponsor:

Susan Bal

Code:

NCT07333261

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

BMS-986453

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Study ID

NCT07333261

Start date

Feb 9, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2041

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single dose BMS-986453

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.

Interventions

BMS-986453

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

Primary outcome measure

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Baseline up to 5 years ]

Central Contacts and Locations

Central contacts

Susan Bal, MD

(205) 934-7645susanbal@uabmc.edu

Margaret Thomas, MPH

margaretathomas@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Susan Bal, MD

2059347645susanbal@uabmc.edu

Luciano J Costa, MD, PhD

ljcosta@uabmc.edu

Principal Investigator:

Susan Bal, MD

More Information

Sponsor

Susan Bal

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Susan Bal on 2026-02-13.