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A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

Study acronym: CARTITUDE-2
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 86 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 7 of 24 entries
    • Site details revised at 1 of 47 sites
  2. Re-verified, no change to tracked fieldsv85
  3. Primary completion pushed from Aug 4, 2026 to Feb 26, 2027
    • Study completion moved earlier from Sep 3, 2029 to Aug 25, 2028
    v84
  4. Primary endpoint(s) modified
    • Enrollment target: 210 to 208
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 23 to 24
    v83
  5. Re-verified, no change to tracked fieldsv82
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 47 sitesv81
  2. Re-verified, no change to tracked fieldsv80
  3. Study completion date: Jan 17, 2028 to Sep 3, 2029v79
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 237 to confirmed 210
    • Site details revised at 47 of 47 sites
    v78
  5. Re-verified, no change to tracked fieldsv77
  6. Site details revised at 1 of 47 sitesv76
  7. Re-verified, no change to tracked fieldsv75
  8. Primary completion date: Dec 1, 2025 to Aug 4, 2026
    • Study completion date: Nov 13, 2028 to Jan 17, 2028
    v74
  9. Site details revised at 4 of 47 sitesv73
  10. 4 versions Re-verified since Apr 2, 2025, no change to tracked fieldsv69-v72
  11. Site details revised at 1 of 47 sitesv68
  12. 2 versions Re-verified since Jan 30, 2025, no change to tracked fieldsv66-v67
  13. Study sites: 46 to 47v65
  14. Re-verified, no change to tracked fieldsv64
  15. Study sites: 44 to 46v63
  16. Re-verified, no change to tracked fieldsv62
  17. Study sites: 42 to 44v61
  18. Study sites: 41 to 42v60
  19. Study sites: 39 to 41v59
  20. Site details revised at 10 of 39 sitesv58
  21. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 169 to 237
    • Study sites: 37 to 39
    v57
  22. Primary completion date: May 30, 2025 to Dec 1, 2025
    • Study sites revised (37)
    v56
  23. Study sites: 33 to 37v55
  24. Re-verified, no change to tracked fieldsv54
  25. Study sites revised (33)v53
  26. 2 versions Re-verified since Jan 30, 2024, no change to tracked fieldsv51-v52
  27. Study sites revised (33)v50
  28. Study completion date: Jun 10, 2027 to Nov 13, 2028
    • Study sites revised (33)
    v49
  29. Study completion date: May 30, 2025 to Jun 10, 2027
    • Site details revised at 1 of 33 sites
    v48
  30. 3 versions Re-verified since Jul 19, 2023, no change to tracked fieldsv45-v47
  31. Site details revised at 1 of 33 sitesv44
  32. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 157 to confirmed 169
    • Site details revised at 33 of 33 sites
    v43
  33. Re-verified, no change to tracked fieldsv42
  34. Primary completion date: Aug 1, 2024 to May 30, 2025
    • Site details revised at 28 of 33 sites
    v41
  35. Study sites: 43 to 33v40
  36. Study completion date: Feb 25, 2026 to May 30, 2025v39
  37. Study sites revised (43)v38
  38. Study Status, Contacts/Locationsv37
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
Trial Details
NCT Number NCT04133636
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov