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

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Etentamig — DRUG
  Intravenous (IV) Infusion
• Iberdomide — DRUG
  Oral Capsule

Study Details

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.

Key Dates

Start date

Aug 7, 2025

Status verified

May 2026

Primary completion

Mar 31, 2036

Completion

Mar 31, 2036

Study Design

Enrollment

135 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (7)

Find similar trials in Beverly Hills, CA

Related Studies

• Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Collection of Tissue Samples for Cancer Research
  Recruiting · National Cancer Institute (NCI) · Sacramento, California
• The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen
  Recruiting · Wake Forest University Health Sciences · Winston-Salem, North Carolina
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado