A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

Celgene

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Mezigdomide; Drug: Dexamethasone; Drug: Elranatamab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06988488

U1111-1317-4901 (Other Identifier)

2025-522090-11 (Other Identifier)

CA057-1040

Details and patient eligibility

About

The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2).
• Measurable MM by local laboratory.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
• Adherence to contraception requirements.

Exclusion criteria

• Prior treatment with mezigdomide.
• Prior treatment with T cell engaging or T cell engager (TCE).
• Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy> 6 months from the start of study therapy
• 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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62 participants in 2 patient groups

Phase 1

Experimental group

Treatment:

Drug: Elranatamab

Drug: Dexamethasone

Drug: Mezigdomide

Phase 2

Experimental group

Treatment:

Drug: Elranatamab

Drug: Dexamethasone

Drug: Mezigdomide