A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

StatusRecruiting
PhasePhase 4
Started

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Record History

The 50 most recent of 56 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Notable Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Primary endpoints: details revised at 2 of 9 entries
    • Site details revised at 1 of 50 sites
  2. Minor Study completion moved earlier from Jun 1, 2042 to Jun 28, 2041v55
  3. 2 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv53-v54
  4. Minor Study completion pushed from Jan 26, 2038 to Jun 1, 2042v52
  5. Minor Study completion pushed from Oct 30, 2037 to Jan 26, 2038v51
Show 44 earlier versionsHide 44 earlier versions
  1. Re-verified, no change to tracked fieldsv50
  2. Minor Site details revised at 11 of 50 sitesv49
  3. 2 versions Re-verified since Dec 4, 2025, no change to tracked fieldsv47-v48
  4. Minor Study sites: 48 to 50v46
  5. Minor Study sites: 47 to 48v45
  6. Minor Enrollment target: 228 to 295
    • Study completion date: Jul 29, 2037 to Oct 30, 2037
    v44
  7. Re-verified, no change to tracked fieldsv43
  8. Minor Study sites: 46 to 47v42
  9. 4 versions Re-verified since Jan 8, 2025, no change to tracked fieldsv38-v41
  10. Minor Study sites: 45 to 46v37
  11. Re-verified, no change to tracked fieldsv36
  12. Minor Study sites revised (45)v35
  13. 3 versions Re-verified since Aug 13, 2024, no change to tracked fieldsv32-v34
  14. Minor Study sites: 44 to 45v31
  15. Minor Study sites: 43 to 44v30
  16. Minor Study sites revised (43)v29
  17. Minor Study sites revised (43)v28
  18. Minor Study sites: 41 to 43v27
  19. Minor Study sites: 39 to 41v26
  20. Minor Study sites: 37 to 39v25
  21. Minor Study sites: 39 to 37v24
  22. Minor Study sites: 35 to 39v23
  23. Minor Study sites revised (35)v22
  24. Minor Study sites: 33 to 35v21
  25. Notable Primary endpoints revised (9)v20
  26. Minor Study sites: 32 to 33v19
  27. Minor Study sites: 29 to 32v18
  28. Minor Study sites: 27 to 29v17
  29. 2 versions Re-verified since Apr 11, 2023, no change to tracked fieldsv15-v16
  30. Minor Study sites: 33 to 27v14
  31. Minor Study sites: 32 to 33v13
  32. Minor Study sites revised (32)v12
  33. Minor Study sites: 33 to 32v11
  34. Minor Site details revised at 1 of 33 sitesv10
  35. Minor Site details revised at 1 of 33 sitesv9
  36. Minor Site details revised at 11 of 33 sitesv8
  37. Minor Study sites: 31 to 33v7
  • 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 collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.
Trial Details
NCT Number NCT05201781
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)
Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 295 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov