NCT06896916

Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Recruiting now Phase 1 Last updated 11 May 2026

What this trial tests

Phase 1 trial testing Etentamig in Multiple Myeloma in 135 participants. Currently enrolling.

Timeline

7 August 2025

Primary endpoint
1 March 2036

1 March 2036

Quick facts

Lead sponsor	AbbVie
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	135
Start date	7 August 2025
Primary completion	1 March 2036
Estimated completion	1 March 2036
Sites	27 locations across United States, Australia, Canada, France, Japan, Netherlands, Norway

Drugs / interventions tested

• Etentamig — full drug profile →
• Iberdomide (iberdomide) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

AbbVie — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
  Time frame: Up to Approximately 56 Days
  DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
• Number of Participants with Adverse Events (AE)s
  Time frame: Up to Approximately 129 Months
  An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. E3 Ubiquitin Ligases: Structures, Biological Functions, Diseases, and Therapy.
   Wang H, Peng J, Li H, Lan Y, et al · · 2025 · cited 1× · PMID 41362701 · DOI 10.1002/mco2.70528