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NCT06896916PHASE1Recruiting

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

AbbVie

Start Date

8/7/2025

Completion Date

3/1/2036

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.

Detailed Description

B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

DRUG

Etentamig

DRUG

Iberdomide

Interested in This Trial?

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Conditions

Multiple Myeloma

Locations

Beverly Hills Cancer Center /ID# 266921

Beverly Hills, California 90211

United States

Colorado Blood Cancer Institute /ID# 273751

Denver, Colorado 80218

United States

Washington University /ID# 266972

St Louis, Missouri 63110

United States

Rutgers Cancer Institute of New Jersey /ID# 266833

New Brunswick, New Jersey 08901

United States

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

New York, New York 10065

United States

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

Hillsborough, North Carolina 27278

United States

Swedish Medical Center - Seattle /ID# 268052

Seattle, Washington 98104

United States

Blacktown Hospital /ID# 265983

Blacktown, New South Wales 2148

Australia

Wollongong Hospital /ID# 265625

Wollongong, New South Wales 2500

Australia

The Alfred Hospital /ID# 265981

Melbourne, Victoria 3004

Australia

Austin Hospital /ID# 265984

Melbourne, Victoria 3084

Australia

Sir Charles Gairdner Hospital /ID# 265985

Nedlands, Western Australia 6009

Australia

University Health Network_Princess Margaret Cancer Centre /ID# 275636

Toronto, Ontario M5G 2M9

Canada

Jewish General Hospital /ID# 267574

Montreal, Quebec H3T 1E2

Canada

Chu de Nice-Hopital Larchet Ii /Id# 266845

Nice, Alpes-Maritimes 06202

France

Hôpital La Timone /ID# 267053

Marseille, Bouches-du-Rhone 13885

France

Chu De Lille - Hopital Claude Huriez /ID# 270193

Lille, Hauts-de-France 59037

France

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

Tours, Indre-et-Loire 37000

France

IUCT Oncopole /ID# 266391

Toulouse, Occitanie 31059

France

National Cancer Center Hospital East /ID# 268343

Kashiwa-shi, Chiba 277-8577

Japan

Kumamoto University Hospital /ID# 270530

Kumamoto, Kumamoto 860-8556

Japan

Dokkyo Medical University Hospital /ID# 271648

Mibu, Tochigi 321-0293

Japan

Nippon Medical School Hospital /ID# 270254

Bunkyo-ku, Tokyo 113-8603

Japan

The Cancer Institute Hospital Of JFCR /ID# 268342

Koto-ku, Tokyo 135-8550

Japan

Amsterdam UMC, Location VUmc /ID# 267670

Amsterdam, North Holland 1081 HV

Netherlands

Universitair Medisch Centrum Utrecht /ID# 267660

Utrecht, 3584 CX

Netherlands

Oslo Universitetssykehus Ulleval /ID# 275433

Oslo, 0450

Norway