Long-term Follow-up for Cilta-cel in Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
Is ciltacabtagene autoleucel (cilta-cel) safe for humans?
What data supports the effectiveness of the treatment Cilta-cel in multiple myeloma?
Cilta-cel, a type of CAR-T cell therapy, has shown strong and lasting responses in patients with multiple myeloma who have already tried other treatments, according to studies like CARTITUDE-1. It has been effective in improving patients' quality of life and has a safety profile that is generally manageable.12567
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Initial Follow-up
Participants are monitored for safety and effectiveness after treatment with cilta-cel, focusing on new incidences of serious adverse events and infections.
Extended Follow-up
Participants continue to be monitored for long-term safety, including serious hematologic disorders and adverse events.
Long-term Safety Monitoring
Participants are assessed for delayed adverse events and long-term safety profile of cilta-cel, including monitoring for new malignancies and autoimmune disorders.
What Are the Treatments Tested in This Trial?
Interventions
- Cilta-cel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University