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Trial record 2 of 2 for:    NCT04133636

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05201781
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Cilta-cel Phase 4

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Actual Study Start Date : March 9, 2022
Estimated Primary Completion Date : July 29, 2037
Estimated Study Completion Date : July 29, 2037

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cilta-cel
Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT04181827, 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. 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.
Other Names:
  • JNJ-68284528
  • LCAR-B38M CAR-T cells




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia [ Time Frame: Up to 15 years ]
    Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.

  5. Number of Participants with New Incidence of Grade >= 3 Infection [ Time Frame: Up to 15 years ]
    Number of participants with new incidence of Grade >=3 infection will be reported.

  6. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 15 years ]
    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.


Secondary Outcome Measures :
  1. Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood [ Time Frame: Up to 15 years ]
    Number of participants with measurable RCL in peripheral blood will be reported.

  2. 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 ]
    Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.

  3. Pattern of Lentiviral Vector Integration Sites [ Time Frame: Up to 15 years ]
    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.

  4. 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 ]
    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.

  5. Overall Survival (OS) [ Time Frame: Up to 15 years ]
    OS is measured from the date of randomization to the date of the participant's death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05201781


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05201781    
Other Study ID Numbers: CR109123
2020-005521-84 ( EudraCT Number )
68284528MMY4002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases