A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations

StatusRecruiting
PhasePhase 1/2
SponsorAbbVie
Started

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Trial flagged as At Risk
Primary endpoints added 7 → 9 primary endpoints
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Record History

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  1. Notable Primary endpoint(s) modified Show 6 more changesShow less
    • Study completion pushed from Dec 2035 to Mar 2036
    • Interventions modified
    • Trial arms changed: 21 → 20
    • Study sites: 34 to 36
    • Secondary endpoints revised (6)
    • Eligibility criteria expanded, about 4 words
  2. Notable Primary endpoint(s) modifiedv27 Show 8 more changesShow less
    • Enrollment increased: 440 → 602 participants
    • Trial sites expanded: 25 → 34 locations
    • Primary completion moved earlier from Feb 2036 to Dec 2035
    • Study completion moved earlier from Mar 2036 to Dec 2035
    • Trial arms changed: 15 → 21
    • Interventions: Carfilzomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Dexamethasone (Drug), Etentamig (Drug), Lenalidomide (Drug) to ABBV-2001 (Drug), Carfilzomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Dexamethasone (Drug), Etentamig (Drug), Iberdomide (Drug)…
    • Secondary endpoints revised (6)
    • Study title shortened, about 7 words
  3. Minor Study sites: 24 to 25v26
  4. Minor Re-verified, no change to tracked fieldsv25
  5. Minor Study sites: 23 to 24v24
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  1. Minor Study sites: 20 to 23v23
  2. Minor Re-verified, no change to tracked fieldsv22
  3. Minor Study sites: 19 to 20v21
  4. Minor Study sites: 18 to 19v20
  5. Minor Study sites: 17 to 18v19
  6. Minor Study sites: 16 to 17v18
  7. Minor Study sites: 15 to 16v17
  8. Minor Study sites: 14 to 15v16
  9. Minor Study sites: 13 to 14v15
  10. Minor Study sites: 11 to 13v14
  11. Minor Study sites: 10 to 11v13
  12. Minor Study sites: 9 to 10v12
  13. Minor Study sites: 8 to 9v11
  14. Minor Study sites: 7 to 8v10
  15. Minor Study sites: 6 to 7v9
  16. Minor Study sites: 5 to 6v8
  17. Minor Re-verified, no change to tracked fieldsv7
  18. Minor Study sites: 4 to 5v6
  19. Minor Study sites: 3 to 4v5
  20. Notable Phase: Phase 1 to Phase 1/2v4 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Primary completion date: Mar 2036 to Feb 2036
    • Start date changed from estimate of Jun 2, 2025 to Jun 30, 2025
  21. Minor 2 versions Re-verified since Apr 23, 2025, no change to tracked fieldsv2-v3
  1. Minor 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.
349 trials monitored
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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. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig and ABBV-2001 in adult participants with MM. Etentamig and ABBV-2001 are investigational drugs being developed for the treatment of MM. This study is broken into 8 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants in substudies 1-4 will receive escalating doses of etentamig alone or with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R), followed by etentamig at the dose levels established during the escalation phases alone or with DR, Kd and R. Participants in substudies 5-8 will receive up to two doses of ABBV-2001 or at the dose level(s) established during the escalation phases of ABBV-2001 with iberdomide, mezigdomide, pomalidomide or lenalidomide. Around 602 adult participants with MM will be enrolled at approximately 55 sites worldwide In substudies 1-3, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or with DR, R or Kd, followed by SC injections of etentamig at the dose levels established during the escalation phases alone or with DR or K. In substudy 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by SC injections of etentamig at the dose levels established during the escalation phase with Lenalidomide. In substudies 5-8, participants will receive up to two doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide, mezigdomide, pomalidomide or lenalidomide followed by SC injections of ABBV-2001 at the dose level(s) established during the escalation phases with oral iberdomide, mezigdomide, pomalidomide or lenalidomide. The study duration is approximately 130 months. 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 NCT06892522
Lead Sponsor AbbVie
Conditions
(from sponsor)
Multiple Myeloma
Related terms Multiple Myeloma, Neoplasms
Enrollment 602 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov