A Phase 4 interventional study of Cilta-cel in Multiple Myeloma, sponsored by Janssen Research & Development, LLC. Recruiting at 50 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 4, Interventional, and Other
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.
Cilta-cel (JNJ-68284528/LCAR-B38M chimeric antigen receptor T-cells [CAR-T]) is an autologous CAR-T therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. There will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. The study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and Year 6 to 15 years after last dose of cilta-cel. Safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). The duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 295 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, NCT04133636, and NCT03548207) in the global development program will be enrolled into this study once the individual's participation in the particular interventional study has ended or a study has been terminated. Participants will not receive any treatment in this study and will be followed-up at least once per year on delayed adverse events for up to 15 years after receiving the last dose of cilta-cel.
Drug: Cilta-cel
Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.
Also known as: JNJ-68284528, LCAR-B38M CAR-T cells
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
Time frame: Up to 15 years
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
Time frame: Up to 15 years
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
Time frame: Up to 15 years
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
Number of participants with new incidence of Grade \>=3 hematologic disorder including hypogammaglobulinemia will be reported.
Time frame: From year 1 up to year 5
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).
Time frame: From year 6 up to year 15
Number of Participants with New Incidence of Grade >= 3 Infection
Number of participants with new incidence of Grade \>=3 infection will be reported.
Time frame: From year 1 up to year 5
Number of Participants with Serious Infection
Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.
Time frame: From year 6 up to year 15
Number of Participants with Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: From year 1 up to year 5
Number of Participants with Related Serious Adverse Events Assessed by the Investigator
Number of participants with related serious adverse events assessed by the investigator will be reported. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: From year 6 up to year 15
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Number of participants with measurable RCL in peripheral blood will be reported.
Time frame: Up to 15 years
Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
Number of participants with CAR transgene level \>LLOQ in peripheral blood cells will be reported.
Time frame: Up to 15 years
Pattern of Lentiviral Vector Integration Sites
Pattern of lentiviral vector integration sites if at least 1 percent (%) of cells in the blood sample or new malignancy are positive for vector sequences will be reported.
Time frame: Up to 15 years
Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
Investigator's response assessment of long term follow-up on CAR-T therapy based on local lab assessments if the participant does not have confirmed disease progression or does not initiate subsequent anti-myeloma therapy at the entry of the study and at any time of during the study will be reported.
Time frame: Up to 15 years
Overall Survival (OS)
OS is measured from the date of randomization to the date of the participant's death.
Time frame: Up to 15 years
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.janssen.com
No publications or documents are linked to this record.
Started Mar 2022 (actual). Primary completion is estimated for Jul 2037, 184 months after the start.
Of 28 phase 4 interventional studies under Multiple Myeloma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 57. This study's planned 184 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ciltacabtagene autoleucel
Janssen Research & Development, LLC →