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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
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
Conditions
Interventions
Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Daratumumab
Subcutaneous Injection
Dexamethasone
Oral Tablet
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