Recruiting
Phase 1

Etentamig & Iberdomide

Sponsor:

AbbVie

Code:

NCT06896916

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Etentamig

Iberdomide

Study Details

Brief summary:

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.

Conditions

Multiple Myeloma

Study ID

NCT06896916

Start date

Aug 7, 2025

Status verified date

May, 2026

Completion date

Mar, 2036

Anticipated

Primary completion date

Mar, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance of 0 or 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).

Study Design

Enrollment

135 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1: ABBV-383 Dose Escalation

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

experimental: Phase 2: ABBV-383 Dose Expansion Dose A

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

experimental: Phase 2: ABBV-383 Dose Expansion Dose B

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

Interventions

Etentamig

Intravenous (IV) Infusion

Iberdomide

Oral Capsule

Primary outcome measure

  • 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 ]
  • Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 129 Months ]

Central Contacts and Locations

Central contacts

Locations

Beverly Hills Cancer Center /ID# 266921

Recruiting

Beverly Hills, California, United States, 90211

Colorado Blood Cancer Institute /ID# 273751

Recruiting

Denver, Colorado, United States, 80218

Washington University /ID# 266972

Recruiting

St Louis, Missouri, United States, 63110

Rutgers Cancer Institute of New Jersey /ID# 266833

Recruiting

New Brunswick, New Jersey, United States, 08901

Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282

Recruiting

New York, New York, United States, 10065

University Of North Carolina Health Care - Hillsborough Campus /ID# 278230

Recruiting

Hillsborough, North Carolina, United States, 27278

Swedish Medical Center - Seattle /ID# 268052

Recruiting

Seattle, Washington, United States, 98104

University Health Network_Princess Margaret Cancer Centre /ID# 275636

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Jewish General Hospital /ID# 267574

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

AbbVie

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Multiple Myeloma
  • Cereblon E3 Ligase Modulatory Drug
  • CELMoD
  • Iberdomide
  • Etentamig
  • ABBV-383

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-05-12.