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
Public ClinicalTrials.gov record NCT07095452. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07095452
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 660 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 7, 2026
- Primary completion
- Dec 31, 2041
- Completion
- Dec 31, 2041
- Last update posted
- Jun 10, 2026
2026 – 2042
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital Scottsdale /ID# 278349 | Scottsdale | Arizona | 85259 | Recruiting |
| Cedars-Sinai Medical Center /ID# 278238 | Los Angeles | California | 90048 | Recruiting |
| Colorado Blood Cancer Institute /ID# 279080 | Denver | Colorado | 80218 | Recruiting |
| Winship Cancer Institute of Emory University /ID# 277667 | Atlanta | Georgia | 30322 | Recruiting |
| Fort Wayne Medical Oncology And Hematology /ID# 278141 | Fort Wayne | Indiana | 46804 | Recruiting |
| Minnesota Oncology - Minneapolis Clinic /ID# 278720 | Minneapolis | Minnesota | 55404 | Recruiting |
| Mayo Clinic Hospital Rochester /ID# 277886 | Rochester | Minnesota | 55905 | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 277844 | New York | New York | 10029 | Recruiting |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946 | New York | New York | 10065 | Recruiting |
| Weill Cornell Medicine Myeloma Center /ID# 278216 | New York | New York | 10065 | Recruiting |
| University of North Carolina at Chapel Hill /ID# 277708 | Chapel Hill | North Carolina | 27514 | Recruiting |
| Willamette Valley Cancer Institute and Research Center /ID# 278721 | Eugene | Oregon | 97401 | Recruiting |
| SCRI Oncology Partners /ID# 278353 | Nashville | Tennessee | 37203 | Recruiting |
| Texas Oncology - The Woodlands /ID# 278726 | The Woodlands | Texas | 77380 | Recruiting |
| Texas Oncology - Northeast Texas /ID# 278725 | Tyler | Texas | 75702 | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 278716 | Fairfax | Virginia | 22031 | Recruiting |
| Blue Ridge Cancer Care - Roanoke /ID# 278722 | Roanoke | Virginia | 24014 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07095452, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07095452 live on ClinicalTrials.gov.