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

StatusRecruiting
PhasePhase 2/3
SponsorAbbVie
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Sep 2040 → Mar 2041
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Record History

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  1. Primary completion pushed from Sep 2040 to Mar 2041
    • Study completion pushed from May 2041 to Jan 2042
  2. Primary completion moved earlier from Jan 2042 to Sep 2040 Show 7 more changesShow less
    • Study completion moved earlier from Jan 2042 to May 2041
    • Interventions modified
    • Trial arms changed: 5 → 7
    • Enrollment target: 660 to 680
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 18 of 29 entries
    • Study sites revised (49)
  3. Study sites: 48 to 49v42
  4. Study sites: 47 to 48v41
  5. Study sites: 46 to 47v40
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 45 to 46v39
  2. Study sites: 44 to 45v38
  1. Trial sites expanded: 39 → 43 locationsv37
  2. Study sites: 39 to 43v36
  3. Study sites: 40 to 39v35
  4. Study sites: 38 to 40v34
  5. Study sites: 37 to 38v33
  6. Study sites: 36 to 37v32
  7. Study sites: 35 to 36v31
  8. 2 versions Re-verified since Apr 6, 2026, no change to tracked fieldsv29-v30
  9. Study sites: 34 to 35v28
  10. Study sites: 32 to 34v27
  11. Study sites: 31 to 32v26
  12. Study sites: 29 to 31v25
  13. Re-verified, no change to tracked fieldsv24
  14. Study sites: 28 to 29v23
  15. Re-verified, no change to tracked fieldsv22
  16. Study sites: 25 to 28v21
  17. Re-verified, no change to tracked fieldsv20
  18. Study sites: 22 to 25v19
  19. Study sites: 21 to 22v18
  20. Re-verified, no change to tracked fieldsv17
  21. Study sites: 20 to 21v16
  22. Study sites: 18 to 20v15
  23. Study sites: 16 to 18v14
  24. Study sites: 15 to 16v13
  25. Study sites: 12 to 15v12
  26. 3 versions Re-verified since Feb 19, 2026, no change to tracked fieldsv9-v11
  27. Study sites: 10 to 12v8
  28. Study sites: 9 to 10v7
  29. Study sites: 8 to 9v6
  30. Re-verified, no change to tracked fieldsv5
  31. Study sites: 7 to 8
    • Primary completion date: Oct 2041 to Jan 2042
    v4
  32. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 7
    • Primary completion date: Jan 2042 to Oct 2041
    • Start date changed from estimate of Nov 12, 2025 to Jan 8, 2026
    • Collaborators: 2 to 1
  33. Collaborators expanded, about 15 wordsv2
  34. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Multiple Myeloma
1,264 trials monitored
See 78 trials at risk
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; a phase 2 dose selection and optimization cohort with 3 study arms and a subcutaneous (SC) safety cohort with 2 study arms. Phase 3 participants will receive etentamig at recommended Phase 3 dose (RP3D). Around 680 adult participants with MM will be enrolled at approximately 155 sites worldwide Participants in the phase 2 dose selection and optimization cohort will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. The Phase 2 subcutaneous (SC) safety cohort participants will receive 1 of 2 doses of etentamig in combination with 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 Details
NCT Number NCT07095452
Lead Sponsor AbbVie
Collaborators: IFM (Intergroupe Français du Myélome); PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 680 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov