Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma

TeneoOne

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Etentamig; Drug: Iberdomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06896916

2024-512146-41-00 (Other Identifier)

M24-555

Details and patient eligibility

About

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.

Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.

In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.

Full description

B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1.
• Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
• All participants must have measurable diseases per central laboratory as outlined in protocol

Exclusion criteria

• Has received prior etentamig treatment.
• Prior exposure to BCMA-targeted therapy as noted in the protocol.
• Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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135 participants in 3 patient groups

Phase 1: ABBV-383 Dose Escalation

Experimental group

Description:

In phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.

Treatment:

Drug: Iberdomide

Drug: Etentamig

Phase 2: ABBV-383 Dose Expansion Dose A

Experimental group

Description:

In phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.

Treatment:

Drug: Iberdomide

Drug: Etentamig

Phase 2: ABBV-383 Dose Expansion Dose B

Experimental group

Description:

In phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.

Treatment:

Drug: Iberdomide

Drug: Etentamig