A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE)

Celgene

Status and phase: Withdrawn; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Elotuzumab; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Alnuctamab; Drug: Carfilzomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06232707

U1111-1281-8227 (Registry Identifier)

CA058-1019

2023-509472-42 (Registry Identifier)

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm A: Alnuctamab

Experimental group

Treatment:

Drug: Alnuctamab

Arm B: Standard of Care Regimens

Active Comparator group

Treatment:

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Daratumumab

Drug: Pomalidomide

Drug: Elotuzumab