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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cilta-cel
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Cancer Center-ScottsdaleRecruiting
  • City of HopeRecruiting
  • University of California, San FranciscoRecruiting
  • University of ChicagoRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Barbara Ann Karmanos Cancer InstituteRecruiting
  • Mayo Clinic RochesterRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Montefiore Medical CenterRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • Mount Sinai Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Levine Cancer InstituteRecruiting
  • University of PennsylvaniaRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • Froedtert MemorialRecruiting
  • UZ GentRecruiting
  • UZ LeuvenRecruiting
  • Peking University Third HospitalRecruiting
  • West China Hospital, Si Chuan UniversityRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • First Hospital, Zhejiang University Medical CollegeRecruiting
  • Jiangsu Province HospitalRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong UniversityRecruiting
  • Shanghai Fourth People's HospitalRecruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • Nagoya City University Hospital
  • Japanese Red Cross Medical Center
  • VU Medisch CentrumRecruiting
  • University Medical Center GroningenRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cilta-cel

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
Number of Participants with New Incidence of Grade >= 3 Infection
Number of participants with new incidence of Grade >=3 infection will be reported.
Number of Participants with Serious Infection
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)
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
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.

Secondary Outcome Measures

Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Number of participants with measurable RCL in peripheral blood will be reported.
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.
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.
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.
Overall Survival (OS)
OS is measured from the date of randomization to the date of the participant's death.

Full Information

First Posted
January 10, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05201781
Brief Title
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Official Title
Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
July 29, 2037 (Anticipated)
Study Completion Date
July 29, 2037 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cilta-cel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cilta-cel
Other Intervention Name(s)
JNJ-68284528, LCAR-B38M CAR-T cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
Description
Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
Time Frame
Up to 15 years
Title
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
Description
Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
Time Frame
Up to 15 years
Title
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
Description
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
Title
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
Description
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
Title
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
Description
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
Title
Number of Participants with New Incidence of Grade >= 3 Infection
Description
Number of participants with new incidence of Grade >=3 infection will be reported.
Time Frame
From year 1 up to year 5
Title
Number of Participants with Serious Infection
Description
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
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
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
Title
Number of Participants with Related Serious Adverse Events Assessed by the Investigator
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Description
Number of participants with measurable RCL in peripheral blood will be reported.
Time Frame
Up to 15 years
Title
Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
Description
Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.
Time Frame
Up to 15 years
Title
Pattern of Lentiviral Vector Integration Sites
Description
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
Title
Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
Description
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
Title
Overall Survival (OS)
Description
OS is measured from the date of randomization to the date of the participant's death.
Time Frame
Up to 15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Cancer Center-Scottsdale
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert Memorial
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Si Chuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital, Zhejiang University Medical College
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Fourth People's Hospital
City
Shanghai
ZIP/Postal Code
200434
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Japanese Red Cross Medical Center
City
Shibuya
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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