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RECRUITING
NCT06896916
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2025-08-07

Completion Date

2036-03

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Etentamig

Intravenous (IV) Infusion

DRUG

Iberdomide

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