Long-term follow-up for patients treated with cilta-cel
Official title: Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Run by Janssen Research & Development, LLC · NCT05201781 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 295 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 50 sites (Phoenix, Arizona and 49 other locations) |
| Status | Recruiting |
| Started | March 9, 2022 |
| Main results expected | July 29, 2037 |
| Study ends | June 30, 2041 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT05201781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have previously received at least one dose of cilta-cel in a company-sponsored clinical study.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies on CAR-T therapies have shown success in understanding long-term effects, making this approach both relevant and necessary.
Who can join: the full rules
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 it's running
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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
Show 44 more locations
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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 -
CHRU de Lille Hopital Claude Huriez
Nord, France Recruiting -
Hopital Saint Louis
Paris, France Recruiting -
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel 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 -
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 -
Nagoya City University Hospital
Nagoya, Japan Active not recruiting -
Japanese Red Cross Medical Center
Shibuya City, Japan Active not recruiting
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
6MW5311 in adults with relapsed or refractory blood cancers
This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.
-
Tailored exercise program to improve quality of life for adults with hematologic cancers
This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.
-
Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma
In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.
-
Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma
This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.
-
SMS text check-ins to track symptoms for people with plasma cell disorders
This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.
-
Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma
This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.