deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04923893

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (CARTITUDE-5)

A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Sponsor: Janssen Research & Development, LLC

Conditions Multiple Myeloma
Interventions Bortezomib Cilta-cel Cyclophosphamide Dexamethasone Fludarabine Lenalidomide
Updated 48 times since 2021 Last updated: Mar 12, 2026 Started: Aug 19, 2021 Primary completion: Feb 14, 2029 Completion: Sep 22, 2036
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04923893, this PHASE3 trial focuses on Multiple Myeloma and remains ongoing. Sponsored by Janssen Research & Development, LLC, it has been updated 48 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Aug 2025 · 2 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 6 months · monthly snapshot

Change History

48 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Feb 2026 — Mar 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Jan 2026 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  4. Dec 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE3

  5. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 43 earlier versions

  1. Oct 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  5. May 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

  6. Apr 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2025 — Apr 2025 [monthly]

    Active Not Recruiting PHASE3

  8. Feb 2025 — Mar 2025 [monthly]

    Active Not Recruiting PHASE3

  9. Jan 2025 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  10. Nov 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE3

  11. Oct 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  12. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  13. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

  14. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE3

  15. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  16. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE3

  17. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE3

  18. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  19. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

  20. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  21. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  22. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  23. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  24. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  25. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  26. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  27. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  28. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  29. Mar 2023 — May 2023 [monthly]

    Recruiting PHASE3

  30. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  31. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  32. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  33. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  34. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  35. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  36. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  37. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  38. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  39. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  40. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  41. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  42. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  43. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

    First recorded

Aug 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Research & Development, LLC
Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus N, Denmark , Amsterdam, Netherlands , Antwerp, Belgium , Athens, Greece , Baltimore, United States , Barcelona, Spain , Basel, Switzerland , Berlin, Germany , Bern, Switzerland , Birmingham, United Kingdom and 112 more locations