Long-term follow-up for patients treated with cilta-cel
Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 295 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 50 sites (Phoenix, Arizona and 49 other locations) |
| Trial ID | NCT05201781 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
- Mayo Clinic Cancer Center-Scottsdale — Phoenix, Arizona, United States (Recruiting)
- City of Hope — Duarte, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Stanford University Medical Center — Stanford, California, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- Kansas University Medical Center — Westwood, Kansas, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Washington University School Of Medicine — St Louis, Missouri, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
- Mount Sinai Medical Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Froedtert Memorial — Milwaukee, Wisconsin, United States (Recruiting)
- UZ Gent — Ghent, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Peking University Third Hospital — Beijing, China (Active_not_recruiting)
- West China Hospital Si Chuan University — Chengdu, China (Active_not_recruiting)
- Fujian Medical University Union Hospital — Fuzhou, China (Active_not_recruiting)
- Sun Yat-sen University Cancer Hospital — Guangzhou, China (Active_not_recruiting)
- First Hospital, Zhejiang University Medical College — Hangzhou, China (Active_not_recruiting)
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing, China (Active_not_recruiting)
- Jiangsu Province Hospital — Nanjing, China (Active_not_recruiting)
- Shanghai Changzheng Hospital — Shanghai, China (Active_not_recruiting)
- Ruijin Hospital Shanghai Jiao Tong University — Shanghai, China (Active_not_recruiting)
- Shanghai Fourth People s Hospital — Shanghai, China (Active_not_recruiting)
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Active_not_recruiting)
- CHRU de Lille Hopital Claude Huriez — Nord, France (Recruiting)
- Hopital Saint Louis — Paris, France (Recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- Nagoya City University Hospital — Nagoya, Japan (Active_not_recruiting)
- Japanese Red Cross Medical Center — Shibuya City, Japan (Active_not_recruiting)
- VU Medisch Centrum — Amsterdam, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Clinica Univ. de Navarra — Pamplona, Spain (Recruiting)
- Hosp Clinico Univ de Salamanca — Salamanca, Spain (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.