Study of BMS-986453 in Newly Diagnosed Multiple Myeloma

Susan Bal

Status and phase: Not yet enrolling; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: BMS-986453

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07333261

000551303 (Other Identifier)

IRB-300015643 (UAB2595)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Single dose BMS-986453

Experimental group

Description:

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.

Treatment:

Drug: BMS-986453