← Back to Search

Long-term Follow-up for Cilta-cel in Multiple Myeloma

Phase 4
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from year 6 up to year 15
Awards & highlights

Study Summary

This trial will follow patients who have received cilta-cel to see if there are any delayed adverse events.

Who is the study for?
This trial is for individuals who have previously received at least one dose of ciltacabtagene autoleucel (cilta-cel) in a company-sponsored study for multiple myeloma and have consented to participate in this long-term follow-up.Check my eligibility
What is being tested?
The study focuses on collecting data over an extended period to monitor delayed side effects and understand the long-term safety of cilta-cel, which is used to treat multiple myeloma.See study design
What are the potential side effects?
While specific side effects are not listed, the trial aims to identify any delayed adverse events associated with long-term use of cilta-cel. These could potentially include immune system reactions or other late-onset complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from year 6 up to year 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and from year 6 up to year 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with New Incidence of Grade >= 3 Infection
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
+6 more
Secondary outcome measures
Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
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 Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cilta-celExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Cilta-cel
2022
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,080 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,189 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,677 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,156 Patients Enrolled for Multiple Myeloma

Media Library

Cilta-cel Clinical Trial Eligibility Overview. Trial Name: NCT05201781 — Phase 4
Multiple Myeloma Research Study Groups: Cilta-cel
Multiple Myeloma Clinical Trial 2023: Cilta-cel Highlights & Side Effects. Trial Name: NCT05201781 — Phase 4
Cilta-cel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05201781 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a variety of locales across Canada currently running this examination?

"Currently, 17 medical centres are recruiting participants for this research including those in Phoenix, San Francisco and Chicago. Therefore, it is recommended that potential enrollees select the nearest clinic to reduce any travelling needs associated with the study."

Answered by AI

Are there any enrolment opportunities for this experiment at present?

"Clinicaltrials.gov confirms that this research endeavour is actively enrolling participants; it was first posted on March 9th 2022, and the details were last adjusted in December of 2022."

Answered by AI

How many volunteers are participating in this clinical research?

"Janssen Research & Development, LLC is in charge of this clinical trial and has commited to enrolling 228 participants who meet the eligibility criteria. This will be accomplished through multiple medical centres around the country like Mayo Clinic Cancer Center-Scottsdale located in Phoenix, Arizona or University of California, San Francisco situated in San Francisco, California."

Answered by AI

What risks should be taken into consideration when utilizing Cilta-cel?

"The safety of Cilta-cel is rated as a 3 due to its Phase 4 trial status, indicating that it has been approved by the appropriate regulatory bodies."

Answered by AI

What are the ultimate objectives for this trial?

"According to the clinical trial sponsor, Janssen Research & Development, LLC, this study's primary goal is determining how many of the participants develop new malignancies or experience recurrence of pre-existing ones. This will be measured over a 15 year time frame. In addition to that, secondary outcomes such as overall survival (defined from date of randomization to date of death), and pattern analysis for lentiviral vector integration sites in cells from blood samples or any new malignancy positive for vector sequences will also be evaluated."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
2022. "A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05201781.
~152 spots leftby Jul 2037
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top