A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma

Celgene

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Mezigdomide; Drug: Alnuctamab; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06163898

CA058-002

U1111-1283-8970 (Other Identifier)

2023-504367-16-00 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participant has a history of RRMM, and must:

• Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy.
• Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy.

Exclusion criteria

• Must not have previously received alnuctamab or mezigdomide.

Note: Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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156 participants in 5 patient groups

Part A

Experimental group

Treatment:

Drug: Dexamethasone

Drug: Alnuctamab

Drug: Mezigdomide

Arm B1

Experimental group

Treatment:

Drug: Dexamethasone

Drug: Alnuctamab

Drug: Mezigdomide

Arm B2

Experimental group

Treatment:

Drug: Dexamethasone

Drug: Alnuctamab

Drug: Mezigdomide

Arm C1

Experimental group

Treatment:

Drug: Dexamethasone

Drug: Alnuctamab

Drug: Mezigdomide

Arm C2

Experimental group

Treatment:

Drug: Alnuctamab