Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05201781




Registration number
NCT05201781
Ethics application status
Date submitted
10/01/2022
Date registered
21/01/2022
Date last updated
9/11/2023

Titles & IDs
Public title
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Scientific title
Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Secondary ID [1] 0 0
2020-005521-84
Secondary ID [2] 0 0
CR109123
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Cilta-cel

Experimental: Cilta-cel - 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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
Timepoint [1] 0 0
Up to 15 years
Primary outcome [2] 0 0
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
Timepoint [2] 0 0
Up to 15 years
Primary outcome [3] 0 0
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
Timepoint [3] 0 0
Up to 15 years
Primary outcome [4] 0 0
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
Timepoint [4] 0 0
From year 1 up to year 5
Primary outcome [5] 0 0
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
Timepoint [5] 0 0
From year 6 up to year 15
Primary outcome [6] 0 0
Number of Participants with New Incidence of Grade >= 3 Infection
Timepoint [6] 0 0
From year 1 up to year 5
Primary outcome [7] 0 0
Number of Participants with Serious Infection
Timepoint [7] 0 0
From year 6 up to year 15
Primary outcome [8] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [8] 0 0
From year 1 up to year 5
Primary outcome [9] 0 0
Number of Participants with Related Serious Adverse Events Assessed by the Investigator
Timepoint [9] 0 0
From year 6 up to year 15
Secondary outcome [1] 0 0
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Timepoint [1] 0 0
Up to 15 years
Secondary outcome [2] 0 0
Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
Timepoint [2] 0 0
Up to 15 years
Secondary outcome [3] 0 0
Pattern of Lentiviral Vector Integration Sites
Timepoint [3] 0 0
Up to 15 years
Secondary outcome [4] 0 0
Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
Timepoint [4] 0 0
Up to 15 years
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 15 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/07/2037
Actual
Sample size
Target
228
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Chengdu
Country [18] 0 0
China
State/province [18] 0 0
Fuzhou
Country [19] 0 0
China
State/province [19] 0 0
Hangzhou
Country [20] 0 0
China
State/province [20] 0 0
Nanjing
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
China
State/province [22] 0 0
Xi'an
Country [23] 0 0
Israel
State/province [23] 0 0
Tel-Aviv
Country [24] 0 0
Japan
State/province [24] 0 0
Nagoya
Country [25] 0 0
Japan
State/province [25] 0 0
Shibuya
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amsterdam
Country [27] 0 0
Netherlands
State/province [27] 0 0
Groningen
Country [28] 0 0
Spain
State/province [28] 0 0
Pamplona
Country [29] 0 0
Spain
State/province [29] 0 0
Salamanca

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05201781
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05201781