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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,003 Previous Clinical Trials
6,397,768 Total Patients Enrolled
76 Trials studying Multiple Myeloma
19,885 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
769 Previous Clinical Trials
3,973,508 Total Patients Enrolled
53 Trials studying Multiple Myeloma
14,806 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
~152 spots leftby Jul 2037
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