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
NCT ID: NCT07095452
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
660 participants
INTERVENTIONAL
2026-01-08
2042-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 2: Etentamig + Daratumumab Dose A
Participants 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.
Etentamig
Intravenous (IV) Infusion
Daratumumab
Subcutaneous Injection
Phase 2: Etentamig + Daratumumab Dose B
Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Etentamig
Intravenous (IV) Infusion
Daratumumab
Subcutaneous Injection
Phase 2: Etentamig + Daratumumab Dose C
Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Etentamig
Intravenous (IV) Infusion
Daratumumab
Subcutaneous Injection
Phase 3: Etentamig + Daratumumab RP3D
Participants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration.
Etentamig
Intravenous (IV) Infusion
Daratumumab
Subcutaneous Injection
Phase 3: Daratumumab, Lenalidomide, and Dexamethasone (DRd)
Participants will receive DRd, as part of the approximately 16 year study duration.
Lenalidomide
Oral Capsule
Daratumumab
Subcutaneous Injection
Dexamethasone
Oral Tablet
Dexamethasone
IV Injection
Interventions
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Etentamig
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Daratumumab
Subcutaneous Injection
Dexamethasone
Oral Tablet
Dexamethasone
IV Injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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IFM (Intergroupe Français du Myélome); PETHEMA (Program for the Study and Treatment of Haematological Malignances)
UNKNOWN
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Colorado Blood Cancer Institute /ID# 279080
Denver, Colorado, United States
Fort Wayne Medical Oncology And Hematology /ID# 278141
Fort Wayne, Indiana, United States
Willamette Valley Cancer Institute and Research Center /ID# 278721
Eugene, Oregon, United States
SCRI Oncology Partners /ID# 278353
Nashville, Tennessee, United States
Texas Oncology - The Woodlands /ID# 278726
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas /ID# 278725
Tyler, Texas, United States
Blue Ridge Cancer Care - Roanoke /ID# 278722
Roanoke, Virginia, United States
Matsuyama Red Cross Hospital /ID# 278660
Matsuyama, Ehime, Japan
Tokai University Hospital /ID# 278157
Isehara, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 278156
Kyoto, Kyoto, Japan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2025-520897-21
Identifier Type: OTHER
Identifier Source: secondary_id
M25-586
Identifier Type: -
Identifier Source: org_study_id
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