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NCT07095452 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Multiple Myeloma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 660
- Enrollment target
- 20
- Study locations
NCT07095452: Recruiting Phase 2 study of Multiple Myeloma, sponsored by AbbVie.
NCT07095452 is a Phase 2 study of Multiple Myeloma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 660 participants, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07095452, a Phase 2 study of Multiple Myeloma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 660 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Daratumumab
- DRUG Etentamig
Study Locations (20)
Texas
- Texas Oncology - The Woodlands /ID# 278726 - The Woodlands
- Texas Oncology - Northeast Texas /ID# 278725 - Tyler
Virginia
- Virginia Cancer Specialists - Fairfax /ID# 278716 - Fairfax
- Blue Ridge Cancer Care - Roanoke /ID# 278722 - Roanoke
Pays de la Loire Region
- Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402 - Nantes
- Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421 - St-Priest-en-Jarez
Colorado
- Colorado Blood Cancer Institute /ID# 279080 - Denver
Indiana
- Fort Wayne Medical Oncology And Hematology /ID# 278141 - Fort Wayne
Minnesota
- Minnesota Oncology - Minneapolis Clinic /ID# 278720 - Minneapolis
New York
- Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946 - New York
Oregon
- Willamette Valley Cancer Institute and Research Center /ID# 278721 - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2026-01-08 |
| Est. Completion | 2042-01 |
| Phase | Phase 2 |
What NCT07095452 shows while recruiting
NCT07095452 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (21% higher).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT07095452 names 20 study sites across 17 states, led by Texas, Virginia, Pays de la Loire Region.
Frequently Asked Questions
What is clinical trial NCT07095452 about?
NCT07095452 is a clinical study titled "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". 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 ...
What is the current status of trial NCT07095452?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 660 participants. The study started on 2026-01-08. Estimated completion is 2042-01.
What conditions does trial NCT07095452 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT07095452?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab (DRUG), Etentamig (DRUG).
Who is sponsoring clinical trial NCT07095452?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07095452 being conducted?
This trial has 20 study locations across Colorado, Indiana, Minnesota, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07095452's enrollment target sits among peer trials
660 34th of 438 higher than 405 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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