Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07095452
PHASE2/PHASE3

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM. Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Official title: Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2026-01-08

Completion Date

2042-01

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Etentamig

Intravenous (IV) Infusion

DRUG

Lenalidomide

Oral Capsule

DRUG

Daratumumab

Subcutaneous Injection

DRUG

Dexamethasone

Oral Tablet

DRUG

Dexamethasone

IV Injection

Locations (35)

Mayo Clinic Hospital Scottsdale /ID# 278349

Scottsdale, Arizona, United States

Colorado Blood Cancer Institute /ID# 279080

Denver, Colorado, United States

Fort Wayne Medical Oncology And Hematology /ID# 278141

Fort Wayne, Indiana, United States

Minnesota Oncology - Minneapolis Clinic /ID# 278720

Minneapolis, Minnesota, United States

Mayo Clinic Hospital Rochester /ID# 277886

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946

New York, New York, United States

University of North Carolina at Chapel Hill /ID# 277708

Chapel Hill, North Carolina, United States

Willamette Valley Cancer Institute and Research Center /ID# 278721

Eugene, Oregon, United States

SCRI Oncology Partners /ID# 278353

Nashville, Tennessee, United States

Texas Oncology - The Woodlands /ID# 278726

The Woodlands, Texas, United States

Texas Oncology - Northeast Texas /ID# 278725

Tyler, Texas, United States

Virginia Cancer Specialists - Fairfax /ID# 278716

Fairfax, Virginia, United States

Blue Ridge Cancer Care - Roanoke /ID# 278722

Roanoke, Virginia, United States

Centre Hospitalier Annecy Genevois /ID# 278406

Epagny Metz Tessy, Auvergne-Rhône-Alpes, France

Chu De Lille - Hopital Claude Huriez /ID# 278413

Lille, Hauts-de-France, France

CHU de Montpellier - Hopital Saint Eloi /ID# 278415

Montpellier, Herault, France

CHRU Tours - Hopital Bretonneau /ID# 279274

Tours, Indre-et-Loire, France

Centre Hospitalier Universitaire de Bordeaux /ID# 278419

Pessac, Nouvelle-Aquitaine, France

IUCT Oncopole /ID# 278403

Toulouse, Occitanie, France

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402

Nantes, Pays de la Loire Region, France

Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421

St-Priest-en-Jarez, Pays de la Loire Region, France

Hopital Saint-Louis /ID# 278429

Paris, France

Nagoya City University Hospital /ID# 278188

Nagoya, Aichi-ken, Japan

Matsuyama Red Cross Hospital /ID# 278660

Matsuyama, Ehime, Japan

Kurume University Hospital /ID# 278209

Kurume-shi, Fukuoka, Japan

Tokai University Hospital /ID# 278157

Isehara, Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 278156

Kyoto, Kyoto, Japan

Hospital Universitario de Gran Canaria Doctor Negrín /ID# 278527

Las Palmas de Gran Canaria, Las Palmas, Spain

Complejo Asistencial Universitario de León - Hospital de León /ID# 278534

León, Leon, Spain

Clinica Universidad de Navarra - Pamplona /ID# 278583

Pamplona, Navarre, Spain

Hospital Clinic de Barcelona /ID# 278532

Barcelona, Spain

Hospital Universitario Ramón y Cajal /ID# 278533

Madrid, Spain

Hospital Universitario 12 de Octubre /ID# 278520

Madrid, Spain

Hospital Universitario de Salamanca /ID# 278530

Salamanca, Spain

Hospital Universitari i Politècnic La Fe /ID# 278525

Valencia, Spain