Full Title:

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM

Myeloma stage or condition:

Multiple Myeloma

Study phase:

Phase 3

Summary/Purpose:

The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).

Detailed Description:

Not available

Treatments:

Drug : Alnuctamab

Specified dose on specified days

Drug : Pomalidomide

Specified dose on specified days

Drug : Daratumumab

Specified dose on specified days

Drug : Elotuzumab

Specified dose on specified days

Drug : Carfilzomib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Study Arms:

Experimental : Arm A: Alnuctamab

Active Comparator : Arm B: Standard of Care Regimens

Study Type:

Interventional

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Recruitment status:

Not yet recruiting

Eligibility criteria:

sion Criteria

Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.

Documented diagnosis of multiple myeloma (MM), and must:. i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy. ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles). iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy. iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.

Must have measurable disease (as determined by central laboratory).

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening. Exclusion Criteria

Active, uncontrolled, or suspected infection.

Known current, or history of, central nervous system involvement of multiple myeloma.

History or presence of clinically relevant CNS pathology.

Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.

Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.

Other protocol-defined Inclusion/Exclusion criteria apply.

Locations / Centres:

Local Institution - 0417, Calgary, Alberta – ()

Local Institution - 0423, Edmonton, Alberta – ()

Local Institution - 0402, London, Ontario – ()

Local Institution - 0395, Toronto, Ontario – ()

Local Institution - 0031, Montreal, Quebec – ()

Local Institution - 0098, Montréal, Quebec – ()

Contacts:

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

Publications:

???

First posted:

2024-01-31

Actual start date:

March 29, 2024

Last updated:

2024-03-27

Estimated enrollment:

466

Estimated completion date:

2030-09-21

Estimated primary completion date:

2025-11-16

Condition:

Multiple Myeloma

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

No

Listed location countries:

Argentina

Australia

Austria

Belgium

Brazil

Canada

Chile

China

Czechia

France

Germany

Greece

Hungary

India

Ireland

Italy

Japan

Korea, Republic of

Norway

Portugal

Romania

Spain

Sweden

Switzerland

Turkey

United Kingdom

United States

NCT number:

NCT06232707

Other study ID numbers:

CA058-1019

Has Data monitoring committee:

Yes

U.S. FDA-regulated product:

Yes

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
Celgene
Industry

Collaborators:

???

Investigators:

Bristol-Myers Squibb Bristol-Myers Squibb

Protocol Registration and Results System:

???

Verification date:

2024-03-01