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NCT05650632

A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma

StatusRecruiting
PhasePhase 1
SponsorAbbVie
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from AbbVie

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Record History

The 50 most recent of 57 versions: 45 with changes below, 5 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Eligibility criteria expanded, about 38 words
    • Enrollment increased: 210 → 250 participants
    • Trial arms changed: 5 → 6
    • Study sites: 46 to 44
    • Secondary endpoints: 1 to 3
  2. Study sites: 45 to 46v56
  3. Site details revised at 1 of 45 sitesv55
  4. Study sites: 44 to 45v54
  5. Study sites: 42 to 44v53
Show 40 earlier versionsHide 40 earlier versions
  1. Study sites: 41 to 42v52
  2. Eligibility criteria expanded, about 45 wordsv51 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 180 to 210
    • Interventions: ABBV-383 (Drug) to Etentamig (ABBV-383) (Drug)
    • Secondary endpoint revised
    • Study arms: 4 to 5
  3. Study sites revised (41)v50
  4. Primary and study completion dates: Mar 2027 to Aug 2029
    • Site details revised at 3 of 41 sites
    v49
  5. Lead sponsor: TeneoOne Inc. to AbbVie
    • Study sites revised (41)
    v48
  6. Study sites: 40 to 41v47
  7. Study sites revised (40)v46
  8. Study sites: 39 to 40v45
  9. Site details revised at 1 of 39 sitesv43
  10. Study sites: 38 to 39v41
  11. Study sites: 37 to 38v40
  12. Study sites: 36 to 37v39
  13. Study sites: 33 to 36v38
  14. Study sites: 32 to 33v37
  15. Primary and study completion dates: Mar 31, 2027 to Mar 2027v36
  16. Study sites: 31 to 32v35
  17. Site details revised at 1 of 31 sitesv34
  18. Study sites revised (31)v33
  19. Study sites: 30 to 31v32
  20. Site details revised at 1 of 30 sitesv31
  21. Study sites: 29 to 30v30
  22. Study sites: 28 to 29v28
  23. Site details revised at 1 of 28 sitesv27
  24. Primary and study completion dates: Dec 29, 2028 to Mar 31, 2027v26
  25. Enrollment target: 120 to 180v25 Show 6 more changesShow less
    • Primary and study completion dates: Jul 12, 2026 to Dec 29, 2028
    • Eligibility criteria expanded, about 50 words
    • Primary endpoints revised (2)
    • Secondary endpoint revised
    • Study sites revised (28)
    • Study arms: 3 to 4
  26. Study sites: 27 to 28v24
  27. Study sites revised (27)v23
  28. Study sites: 24 to 27v22
  29. Enrollment target: 80 to 120
    • Study sites: 18 to 24
    • Study arms: 2 to 3
    v20
  30. Study sites: 17 to 18v19
  31. Study sites: 16 to 17v18
  32. Study sites: 15 to 16v17
  33. Study sites: 14 to 15v16
  34. Study sites: 13 to 14v15
  35. Study sites: 12 to 13v14
  36. Study sites: 11 to 12v13
  37. Study sites: 10 to 11v12
  38. Study sites: 9 to 10v11
  39. Primary and study completion dates: May 30, 2026 to Jul 12, 2026v9
  40. Study sites: 34 to 9v8
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Arm A (Part 1 and Part 2) Arm C, Arm D, and Arm E: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events
Timeframe: Up to Day 28
Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])
Timeframe: Up to Day 28

Secondary (3)

Arm A, Arm C. Arm D, and Arm E: Number of Cytokine Release Syndrome (CRS) Events
Arm E-Overall Response Rate (ORR)
Arm E-Duration of Response (DOR)

Arms and interventions

Arm A (Part 1): ABBV-383 Dose EscalationExperimental

B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.

Arm A (Part 2): ABBV-383 Dose ExpansionExperimental

BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.

Arm B: ABBV-383 BCMA ExposedExperimental

Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.

Arm C: ABBV-383 Step UpExperimental

Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

Arm D: ABBV-383 Step UpExperimental

Participants who have received at least 1 and no more than 3 prior lines of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

Arm E: ABBV-383 Step UpExperimental

Participants who have received 1 line of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles.

Drugs: Etentamig (ABBV-383)

Sites

44 sites in 7 countries

United States 25, France 6, Israel 4, Spain 3, Canada 2, Denmark 2, United Kingdom 2