Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07095452

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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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 | DecenTrialz