Full Title:

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component

Myeloma stage or condition:

Multiple Myeloma

Study phase:

Phase 1

Summary/Purpose:

The purpose of this study is to establish a safe and tolerable dose of BMS-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (RRMM).

Detailed Description:

Not available

Treatments:

Drug : BMS-986393

Specified dose on specified days

Drug : Alnuctamab

Specified dose on specified days

Drug : Mezigdomide

Specified dose on specified days

Drug : Iberdomide

Specified dose on specified days

Study Arms:

Experimental : Arm A: BMS-986393 + Alnuctamab

Experimental : Arm B: BMS-986393 + Mezigdomide

Experimental : Arm C: BMS-986393 + Iberdomide

Study Type:

Interventional

Study Design:

Allocation: Non Randomized

Intervention Model: Sequential

Primary Purpose: Treatment

Masking: None

Recruitment status:

Recruiting

Eligibility criteria:

usion Criteria:

* History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2) * Measurable multiple myeloma (MM) * Eastern Cooperative Oncology Group performance status of 0-1

Exclusion Criteria:

* Condition that confounds the ability to interpret data from the study * Known active or history of central nervous system (CNS) involvement of MM Note: Other protocol-defined inclusion/exclusion criteria apply

Locations / Centres:

Tom Baker Cancer Center, Calgary, Alberta – Recruiting

Local Institution - 0024, Toronto, Ontario – Not yet recruiting

Contacts:

Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]

Publications:

???

First posted:

Not available

Actual start date:

2024-02-22

Last updated:

2024-08-15

Estimated enrollment:

111

Estimated completion date:

2028-08-01

Estimated primary completion date:

2028-08-01

Condition:

Multiple Myeloma

Gender:

All

Ages:

18 Years-

Accepts healthy volunteers:

Not available

Listed location countries:

Not available

NCT number:

NCT06121843

Other study ID numbers:

CA088-1005

Has Data monitoring committee:

Not available

U.S. FDA-regulated product:

Yes

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Industry

Collaborators:

???

Investigators:

Bristol-Myers Squibb Bristol-Myers Squibb

Protocol Registration and Results System:

???

Verification date:

2024-08-01