Multiple MyelomaPhase 4NCT05201781
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
A Phase 4 study testing Cilta-cel in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 50 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cilta-cel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 9 Mar 2022to 30 Jun 2041
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
50 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
50 sites in 8 countries
United States28 sites, 28 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02215
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
University of Chicago
Chicago, Illinois, 60637
- Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
- Recruiting
Froedtert Memorial
Milwaukee, Wisconsin, 53226
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
- Recruiting
Mount Sinai Medical Center
New York, New York, 10029
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona, 85054
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55902
- Recruiting
University of California San Francisco
San Francisco, California, 94143
- Recruiting
Washington University School Of Medicine
St Louis, Missouri, 63110
- Recruiting
Stanford University Medical Center
Stanford, California, 94305-5623
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
- Recruiting
Kansas University Medical Center
Westwood, Kansas, 66205
China11 sites
- Active, not recruiting
Peking University Third Hospital
Beijing, 100191
- Active, not recruiting
West China Hospital Si Chuan University
Chengdu, 610041
- Active, not recruiting
Fujian Medical University Union Hospital
Fuzhou, 350000
- Active, not recruiting
Sun Yat-sen University Cancer Hospital
Guangzhou, 510060
- Active, not recruiting
First Hospital, Zhejiang University Medical College
Hangzhou, 310003
- Active, not recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008
- Active, not recruiting
Jiangsu Province Hospital
Nanjing, 210029
- Active, not recruiting
Shanghai Changzheng Hospital
Shanghai, 200003
- Active, not recruiting
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
- Active, not recruiting
Shanghai Fourth People s Hospital
Shanghai, 200434
- Active, not recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004
Belgium2 sites, 2 recruiting
- Recruiting
UZ Gent
Ghent, 9000
- Recruiting
UZ Leuven
Leuven, 3000
France2 sites, 2 recruiting
- Recruiting
CHRU de Lille Hopital Claude Huriez
Nord, 59037
- Recruiting
Hopital Saint Louis
Paris, 75010
Japan2 sites
- Active, not recruiting
Nagoya City University Hospital
Nagoya, 467 8602
- Active, not recruiting
Japanese Red Cross Medical Center
Shibuya City, 150-8935
Netherlands2 sites, 2 recruiting
- Recruiting
VU Medisch Centrum
Amsterdam, 1081 HV
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Spain2 sites, 2 recruiting
- Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
- Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Cilta-cel
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilta-celDrug
Also called JNJ-68284528, LCAR-B38M CAR-T cells
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.
| Study group | Role | What they receive |
|---|---|---|
| Cilta-cel | Experimental | 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. Receives: Drug: Cilta-cel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From year 6 up to year 15
Secondary outcomes (5)
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Number of participants with measurable RCL in peripheral blood will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 15 years
Overall Survival (OS)
OS is measured from the date of randomization to the date of the participant's death.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start9 Mar 2022
- Primary completion29 Jul 2037 (estimated)
- Study completion30 Jun 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201781
- Sponsor's protocol ID
- CR109123
- Other IDs
- 68284528MMY4002, 2020-005521-84, 2023-505530-10-00, 2023
- Status last verified
- Nov 2026
- First submitted
- 10 Jan 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
- ClinicalTrials.gov ID
- NCT05201781
- Acronym / sponsor ID
- CR109123
- Conditions
- Multiple Myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 295 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 29 Jul 2037 (estimated)
- Study completion
- 30 Jun 2041 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cilta-cel | Experimental | Drug: Cilta-celParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilta-celAlso: JNJ-68284528, LCAR-B38M CAR-T cellsParticipants 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. | Drug | Cilta-cel |
Primary outcome
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
Time frame: Up to 15 years
Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
Time frame: Up to 15 years
Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
Time frame: Up to 15 years
Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
Time frame: From year 1 up to year 5
Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
Time frame: From year 6 up to year 15
Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).
Number of Participants with New Incidence of Grade >= 3 Infection
Time frame: From year 1 up to year 5
Number of participants with new incidence of Grade >=3 infection will be reported.
Number of Participants with Serious Infection
Time frame: From year 6 up to year 15
Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: From year 1 up to year 5
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.
Number of Participants with Related Serious Adverse Events Assessed by the Investigator
Time frame: From year 6 up to year 15
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.
5 secondary outcomes
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
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
Time frame: Up to 15 years
Pattern of Lentiviral Vector Integration Sites
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
Time frame: Up to 15 years
Overall Survival (OS)
Time frame: Up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
50 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilta-cel in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 50 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, China, Belgium, France, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy (time frame: Up to 15 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.