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
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
3 other identifiers
interventional
660
4 countries
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Jan 2026
Longer than P75 for phase_2 multiple-myeloma
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 31, 2025
CompletedStudy Start
First participant enrolled
January 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2042
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2042
June 11, 2026
June 1, 2026
16 years
July 24, 2025
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to Approximately 16 Years
Phase 2: Change in Clinical Activity
Clinical activity is defined as change in response rates \[Overall Response Rate (ORR), Complete Response (CR) or Better, Very Good Partial Response (VGPR), Partial Response (PR)\] as determined International Myeloma Working Group (IMWG (2016).
Up to Approximately 52 weeks
Phase 3: Minimal Residual Disease (MRD) Negative CR Rate
MRDnegCR rate, is defined as the percentage of participants who have achieved stringent complete response (sCR) or CR as assessed by independent review committee (IRC) and have negative MRD defined at 10\^-5 threshold as assessed by next generation sequencing (NGS).
Up to Approximately 52 weeks
Phase 3: Progression-Free Survival (PFS)
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by IRC per IMWG (2016) response criteria, or death, whichever occurs first.
Up to Approximately 130 Months
Secondary Outcomes (29)
Phase 2: MRD Negative CR Rate
Up to Approximately 52 Weeks
Phase 2: PFS
Up to Approximately 130 Months
Phase 2: Sustained MRD Negativity Rate
Up to Approximately 12 Months
Phase 2: Area Under the Serum Concentration-Time Curve (AUC)
Up to Approximately 12 Months
Phase 2: Overall Survival (OS)
Up to Approximately 16 Years
- +24 more secondary outcomes
Study Arms (5)
Phase 2: Etentamig + Daratumumab Dose A
EXPERIMENTALParticipants 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.
Phase 2: Etentamig + Daratumumab Dose B
EXPERIMENTALParticipants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Phase 2: Etentamig + Daratumumab Dose C
EXPERIMENTALParticipants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Phase 3: Etentamig + Daratumumab RP3D
EXPERIMENTALParticipants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration.
Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd)
EXPERIMENTALParticipants will receive DRd, as part of the approximately 16 year study duration.
Interventions
Subcutaneous Injection
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
- Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
- Participant who has known active central nervous system involvement of MM.
- Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Mayo Clinic Hospital Scottsdale /ID# 278349
Scottsdale, Arizona, 85259, United States
Cedars-Sinai Medical Center /ID# 278238
Los Angeles, California, 90048, United States
Colorado Blood Cancer Institute /ID# 279080
Denver, Colorado, 80218, United States
Winship Cancer Institute of Emory University /ID# 277667
Atlanta, Georgia, 30322, United States
Fort Wayne Medical Oncology And Hematology /ID# 278141
Fort Wayne, Indiana, 46804, United States
Minnesota Oncology - Minneapolis Clinic /ID# 278720
Minneapolis, Minnesota, 55404, United States
Mayo Clinic Hospital Rochester /ID# 277886
Rochester, Minnesota, 55905, United States
Icahn School of Medicine at Mount Sinai /ID# 277844
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946
New York, New York, 10065, United States
Weill Cornell Medicine Myeloma Center /ID# 278216
New York, New York, 10065, United States
University of North Carolina at Chapel Hill /ID# 277708
Chapel Hill, North Carolina, 27514, United States
Willamette Valley Cancer Institute and Research Center /ID# 278721
Eugene, Oregon, 97401, United States
SCRI Oncology Partners /ID# 278353
Nashville, Tennessee, 37203, United States
Texas Oncology - The Woodlands /ID# 278726
The Woodlands, Texas, 77380, United States
Texas Oncology - Northeast Texas /ID# 278725
Tyler, Texas, 75702, United States
Virginia Cancer Specialists - Fairfax /ID# 278716
Fairfax, Virginia, 22031, United States
Blue Ridge Cancer Care - Roanoke /ID# 278722
Roanoke, Virginia, 24014, United States
Centre Hospitalier Annecy Genevois /ID# 278406
Epagny Metz Tessy, Auvergne-Rhône-Alpes, 74370, France
Centre Hospitalier De Dunkerque-Hospital Alexandra Lepeve /ID# 278399
Dunkirk, Hauts-de-France, 59385, France
Chu De Lille - Hopital Claude Huriez /ID# 278413
Lille, Hauts-de-France, 59037, France
CHU de Montpellier - Hopital Saint Eloi /ID# 278415
Montpellier, Herault, 34295, France
CHRU Tours - Hopital Bretonneau /ID# 279274
Tours, Indre-et-Loire, 37044, France
CH Bretagne Atlantique /ID# 278422
Vannes, Morbihan, 56000, France
Centre Hospitalier Universitaire de Bordeaux /ID# 278419
Pessac, New Aquitaine, 33604, France
Centre Hospitalier Universitaire de Poitiers /ID# 278398
Poitiers, New Aquitaine, 86021, France
IUCT Oncopole /ID# 278403
Toulouse, Occitanie, 31059, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402
Nantes, Pays de la Loire Region, 44000, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421
St-Priest-en-Jarez, Pays de la Loire Region, 42270, France
HCL - Hopital Lyon Sud /ID# 282145
Pierre-Bénite, Rhone, 69495, France
Hopital Saint-Louis /ID# 278429
Paris, 75010, France
Hopital Saint Antoine /ID# 278428
Paris, 75012, France
Hopital Universitaire Necker Enfants Malades /ID# 278426
Paris, Île-de-France Region, 75015, France
Nagoya City University Hospital /ID# 278188
Nagoya, Aichi-ken, 467-8602, Japan
Matsuyama Red Cross Hospital /ID# 278660
Matsuyama, Ehime, 790-8524, Japan
Kurume University Hospital /ID# 278209
Kurume-shi, Fukuoka, 830-0011, Japan
Tokai University Hospital /ID# 278157
Isehara, Kanagawa, 259-1193, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 278156
Kyoto, Kyoto, 602-8566, Japan
Complejo Hospitalario Universitario de Santiago /ID# 278531
Santiago de Compostela, A Coruna, 15706, Spain
Institut Catala d'Oncologia (ICO) - Badalona /ID# 278522
Badalona, Barcelona, 08916, Spain
Hospital Universitario Marques de Valdecilla /ID# 278535
Santander, Cantabria, 39008, Spain
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 278527
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Clinica Universidad de Navarra - Pamplona /ID# 278583
Pamplona, Navarre, 31008, Spain
Hospital Clinic de Barcelona /ID# 278532
Barcelona, 08036, Spain
Complejo Asistencial Universitario de Leon - Hospital de Leon /ID# 278534
León, 24071, Spain
Hospital General Universitario Gregorio Maranon /ID# 278551
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal /ID# 278533
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre /ID# 278520
Madrid, 28041, Spain
Hospital Universitario de Salamanca /ID# 278530
Salamanca, 37007, Spain
Hospital Universitari i Politecnic La Fe /ID# 278525
Valencia, 46026, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2025
First Posted
July 31, 2025
Study Start
January 8, 2026
Primary Completion (Estimated)
January 1, 2042
Study Completion (Estimated)
January 1, 2042
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.