A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma

AbbVie

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Relapsed or Refractory Multiple Myeloma

Treatments: Drug: Teclistamab; Drug: Etentamig; Drug: Daratumumab; Drug: Dexamethasone; Drug: Carfilzomib; Drug: Pomalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07728188

2026-525596-11-00 (EU Trial (CTIS) Number)

M22-538

Details and patient eligibility

About

Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide.

Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide.

Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Enrollment: 520 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
• Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
• Adequate organ function and performance status

Exclusion criteria

• Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
• Known central nervous system involvement of MM
• Known history of other active malignancies within the past 3 years (with specific exceptions)
• Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 3 patient groups

Safety Run-In: Etentamig Plus Pomalidomide

Experimental group

Description:

Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.

Treatment:

Drug: Pomalidomide

Drug: Etentamig

Randomized Portion: Etentamig Plus Pomalidomide

Experimental group

Description:

Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.

Treatment:

Drug: Pomalidomide

Drug: Etentamig

Randomized Portion: Standard Available Therapy (SAT)

Active Comparator group

Description:

Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.

Treatment:

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Daratumumab

Drug: Teclistamab