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
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT).
• IMWG Myeloma Frailty Index Score of \>= 1
• All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
‣ Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
⁃ Urine M-protein \>= 200 mg/24 hours.
⁃ Serum free light chain (FLC) \>= 100 mg/L (\>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.
Locations
United States
Arizona
Mayo Clinic Hospital Scottsdale /ID# 278349
RECRUITING
Scottsdale
Colorado
Colorado Blood Cancer Institute /ID# 279080
RECRUITING
Denver
Indiana
Fort Wayne Medical Oncology And Hematology /ID# 278141
University of North Carolina at Chapel Hill /ID# 277708
RECRUITING
Chapel Hill
New York
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946
RECRUITING
New York
Oregon
Willamette Valley Cancer Institute and Research Center /ID# 278721
RECRUITING
Eugene
Tennessee
SCRI Oncology Partners /ID# 278353
RECRUITING
Nashville
Texas
Texas Oncology - The Woodlands /ID# 278726
RECRUITING
The Woodlands
Texas Oncology - Northeast Texas /ID# 278725
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists - Fairfax /ID# 278716
RECRUITING
Fairfax
Blue Ridge Cancer Care - Roanoke /ID# 278722
RECRUITING
Roanoke
Other Locations
France
Centre Hospitalier Annecy Genevois /ID# 278406
RECRUITING
Epagny Metz Tessy
Chu De Lille - Hopital Claude Huriez /ID# 278413
RECRUITING
Lille
CHU de Montpellier - Hopital Saint Eloi /ID# 278415
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402
RECRUITING
Nantes
Hopital Saint-Louis /ID# 278429
RECRUITING
Paris
Centre Hospitalier Universitaire de Bordeaux /ID# 278419
RECRUITING
Pessac
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421
RECRUITING
St-priest-en-jarez
IUCT Oncopole /ID# 278403
RECRUITING
Toulouse
CHRU Tours - Hopital Bretonneau /ID# 279274
RECRUITING
Tours
CH Bretagne Atlantique /ID# 278422
RECRUITING
Vannes
Japan
Tokai University Hospital /ID# 278157
RECRUITING
Isehara
Kurume University Hospital /ID# 278209
RECRUITING
Kurume-shi
University Hospital Kyoto Prefectural University of Medicine /ID# 278156
RECRUITING
Kyoto
Matsuyama Red Cross Hospital /ID# 278660
RECRUITING
Matsuyama
Nagoya City University Hospital /ID# 278188
RECRUITING
Nagoya
Spain
Hospital Clinic de Barcelona /ID# 278532
RECRUITING
Barcelona
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 278527
RECRUITING
Las Palmas De Gran Canaria
Complejo Asistencial Universitario de Leon - Hospital de Leon /ID# 278534
RECRUITING
León
Hospital General Universitario Gregorio Maranon /ID# 278551
RECRUITING
Madrid
Hospital Universitario 12 de Octubre /ID# 278520
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal /ID# 278533
RECRUITING
Madrid
Clinica Universidad de Navarra - Pamplona /ID# 278583
RECRUITING
Pamplona
Hospital Universitario de Salamanca /ID# 278530
RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla /ID# 278535
RECRUITING
Santander
Hospital Universitari i Politècnic La Fe /ID# 278525
RECRUITING
Valencia
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date:2026-01-08
Estimated Completion Date:2042-01
Participants
Target number of participants:660
Treatments
Experimental: Phase 2: Etentamig + Daratumumab Dose A
Participants will receive etentamig dose A in combination with daratumumab until the recommended phase 3 dose (RP3D), as part of the approximately 16 year study duration.
Experimental: Phase 2: Etentamig + Daratumumab Dose B
Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Experimental: Phase 2: Etentamig + Daratumumab Dose C
Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.