RecruitingPhase 1NCT06896916

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

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

Sponsor

AbbVie

Enrollment

135 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments for multiple myeloma — a cancer of plasma cells in the bone marrow — that has returned or stopped responding to prior therapies. The combination includes etentamig, a bispecific antibody given by IV infusion, and a CELMoD agent (a type of oral drug that helps the immune system target cancer cells). This is a Phase 1/2 study to evaluate safety and how well the combination works. **You may be eligible if...** - You are an adult with confirmed multiple myeloma that has relapsed (returned) or is refractory (not responding) to your last treatment - You are physically well enough to participate (ECOG performance status 0 or 1) - You have measurable disease on lab tests - Your kidney, liver, and blood counts meet the required thresholds **You may NOT be eligible if...** - You have previously received etentamig - You have active brain involvement from myeloma - You have uncontrolled infections - You have a history of certain autoimmune conditions or have received certain prior therapies that would make this combination unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtentamig

Intravenous (IV) Infusion

DRUGIberdomide

Oral Capsule

Locations(26)

Beverly Hills Cancer Center /ID# 266921

Beverly Hills, California, United States

Colorado Blood Cancer Institute /ID# 273751

Denver, Colorado, United States

Washington University /ID# 266972

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey /ID# 266833

New Brunswick, New Jersey, United States

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

New York, New York, United States

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

Hillsborough, North Carolina, United States

Swedish Medical Center - Seattle /ID# 268052

Seattle, Washington, United States

Blacktown Hospital /ID# 265983

Blacktown, New South Wales, Australia

Wollongong Hospital /ID# 265625

Wollongong, New South Wales, Australia

The Alfred Hospital /ID# 265981

Melbourne, Victoria, Australia

Austin Hospital /ID# 265984

Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital /ID# 265985

Nedlands, Western Australia, Australia

University Health Network_Princess Margaret Cancer Centre /ID# 275636

Toronto, Ontario, Canada

Jewish General Hospital /ID# 267574

Montreal, Quebec, Canada

Chu de Nice-Hopital Larchet Ii /Id# 266845

Nice, Alpes-Maritimes, France

Hôpital La Timone /ID# 267053

Marseille, Bouches-du-Rhone, France

Chu De Lille - Hopital Claude Huriez /ID# 270193

Lille, Hauts-de-France, France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694

Tours, Indre-et-Loire, France

IUCT Oncopole /ID# 266391

Toulouse, Occitanie, France

Kumamoto University Hospital /ID# 270530

Kumamoto, Kumamoto, Japan

Dokkyo Medical University Hospital /ID# 271648

Mibu, Tochigi, Japan

Nippon Medical School Hospital /ID# 270254

Bunkyo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 268342

Koto-ku, Tokyo, Japan

Amsterdam UMC, Location VUmc /ID# 267670

Amsterdam, North Holland, Netherlands

Universitair Medisch Centrum Utrecht /ID# 267660

Utrecht, Netherlands

Oslo Universitetssykehus Ulleval /ID# 275433

Oslo, Norway

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NCT06896916

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