Study of BMS-986453 in Newly Diagnosed Multiple Myeloma

NCT ID: NCT07333261

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2043-01-31

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.

Detailed Description

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BMS-986453

Intervention Type: DRUG

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

Interventions

BMS-986453

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Susan Bal

OTHER

Sponsor Role: lead

Responsible Party

Susan Bal

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan Bal, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Luciano A Costa, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Central Contacts

Susan Bal, MD

Role: CONTACT

susanbal@uabmc.edu

(205) 934-7645

Margaret Thomas, MPH

Role: CONTACT

margaretathomas@uabmc.edu

Facility Contacts

Susan Bal, MD

Role: primary

susanbal@uabmc.edu

Luciano Costa, MD

Role: backup

ljcosta@uabmc.edu

Other Identifiers

000551303

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300015643 (UAB2595)

Identifier Type: -

Identifier Source: org_study_id