Long-term follow-up for patients treated with cilta-cel

Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Phase 4 Interventional Janssen Research & Development, LLC · NCT05201781

This study is tracking the long-term effects and safety of a treatment called cilta-cel in people with multiple myeloma to see how they do over up to 15 years after their therapy.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment295 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor
Locations50 sites (Phoenix, Arizona and 49 other locations)
Trial IDNCT05201781 on ClinicalTrials.gov

What this trial studies

This study aims to gather long-term follow-up data on delayed adverse events in patients who have previously received ciltacabtagene autoleucel (cilta-cel) for multiple myeloma. It focuses on characterizing the long-term safety profile of this CAR-T therapy, which targets B-cell maturation antigen (BCMA). Participants will not receive any new treatment during the study; instead, they will be monitored for adverse events, laboratory results, and physical examinations over a period of up to 15 years. The study is divided into two phases: the first five years after the last dose and then from year six to fifteen.

Who should consider this trial

Good fit: Ideal candidates are individuals who have previously received at least one dose of cilta-cel in a company-sponsored clinical study.

Not a fit: Patients who have not been treated with cilta-cel or those who do not provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and potential toxicities associated with cilta-cel treatment.

How similar studies have performed: Other studies on CAR-T therapies have shown success in understanding long-term effects, making this approach both relevant and necessary.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
* Participants who have provided informed consent for this study

Where this trial is running

Phoenix, Arizona and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.