Actively Recruiting
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
Led by AbbVie · Updated on 2026-05-13
660
Participants Needed
39
Research Sites
833 weeks
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
I
IFM (Intergroupe Français du Myélome); PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed new diagnosis of multiple myeloma according to International Myeloma Working Group criteria
- Not suitable for high-dose chemotherapy and stem cell transplant due to factors affecting treatment tolerability
- Myeloma Frailty Index Score of 1 or higher
- Measurable disease with at least one of the following within 28 days before enrollment:
- Serum M-protein 0.5 g/dL or higher
- Urine M-protein 200 mg/24 hours or higher
- Serum free light chain 100 mg/L or higher with abnormal kappa lambda ratio if no measurable M-protein
You will not qualify if you...
- Prior or current systemic therapy or stem cell transplant for multiple myeloma except short course corticosteroids
- Received investigational treatment within 30 days or 5 half-lives before study treatment or enrolled in another clinical study
- Known active central nervous system involvement of multiple myeloma
- History of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within last 6 months that may affect participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Mayo Clinic Hospital Scottsdale /ID# 278349
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Colorado Blood Cancer Institute /ID# 279080
Denver, Colorado, United States, 80218
Actively Recruiting
3
Fort Wayne Medical Oncology And Hematology /ID# 278141
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
4
Minnesota Oncology - Minneapolis Clinic /ID# 278720
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
5
Mayo Clinic Hospital Rochester /ID# 277886
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946
New York, New York, United States, 10065
Actively Recruiting
7
University of North Carolina at Chapel Hill /ID# 277708
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
8
Willamette Valley Cancer Institute and Research Center /ID# 278721
Eugene, Oregon, United States, 97401
Actively Recruiting
9
SCRI Oncology Partners /ID# 278353
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Texas Oncology - The Woodlands /ID# 278726
The Woodlands, Texas, United States, 77380
Actively Recruiting
11
Texas Oncology - Northeast Texas /ID# 278725
Tyler, Texas, United States, 75702
Actively Recruiting
12
Virginia Cancer Specialists - Fairfax /ID# 278716
Fairfax, Virginia, United States, 22031
Actively Recruiting
13
Blue Ridge Cancer Care - Roanoke /ID# 278722
Roanoke, Virginia, United States, 24014
Actively Recruiting
14
Centre Hospitalier Annecy Genevois /ID# 278406
Epagny Metz Tessy, Auvergne-Rhône-Alpes, France, 74370
Actively Recruiting
15
Chu De Lille - Hopital Claude Huriez /ID# 278413
Lille, Hauts-de-France, France, 59037
Actively Recruiting
16
CHU de Montpellier - Hopital Saint Eloi /ID# 278415
Montpellier, Herault, France, 34295
Actively Recruiting
17
CHRU Tours - Hopital Bretonneau /ID# 279274
Tours, Indre-et-Loire, France, 37044
Actively Recruiting
18
CH Bretagne Atlantique /ID# 278422
Vannes, Morbihan, France, 56000
Actively Recruiting
19
Centre Hospitalier Universitaire de Bordeaux /ID# 278419
Pessac, New Aquitaine, France, 33604
Actively Recruiting
20
IUCT Oncopole /ID# 278403
Toulouse, Occitanie, France, 31059
Actively Recruiting
21
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
22
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421
St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
Actively Recruiting
23
Hopital Saint-Louis /ID# 278429
Paris, France, 75010
Actively Recruiting
24
Hopital Saint Antoine /ID# 278428
Paris, France, 75012
Actively Recruiting
25
Nagoya City University Hospital /ID# 278188
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
26
Matsuyama Red Cross Hospital /ID# 278660
Matsuyama, Ehime, Japan, 790-8524
Actively Recruiting
27
Kurume University Hospital /ID# 278209
Kurume-shi, Fukuoka, Japan, 830-0011
Actively Recruiting
28
Tokai University Hospital /ID# 278157
Isehara, Kanagawa, Japan, 259-1193
Actively Recruiting
29
University Hospital Kyoto Prefectural University of Medicine /ID# 278156
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
30
Hospital Universitario Marques de Valdecilla /ID# 278535
Santander, Cantabria, Spain, 39008
Actively Recruiting
31
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 278527
Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
Actively Recruiting
32
Clinica Universidad de Navarra - Pamplona /ID# 278583
Pamplona, Navarre, Spain, 31008
Actively Recruiting
33
Hospital Clinic de Barcelona /ID# 278532
Barcelona, Spain, 08036
Actively Recruiting
34
Complejo Asistencial Universitario de Leon - Hospital de Leon /ID# 278534
León, Spain, 24071
Actively Recruiting
35
Hospital General Universitario Gregorio Maranon /ID# 278551
Madrid, Spain, 28007
Actively Recruiting
36
Hospital Universitario Ramon y Cajal /ID# 278533
Madrid, Spain, 28034
Actively Recruiting
37
Hospital Universitario 12 de Octubre /ID# 278520
Madrid, Spain, 28041
Actively Recruiting
38
Hospital Universitario de Salamanca /ID# 278530
Salamanca, Spain, 37007
Actively Recruiting
39
Hospital Universitari i Politècnic La Fe /ID# 278525
Valencia, Spain, 46026
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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