UPCC 41421 Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel

Long-term Follow-up Study for Participants Previously Treated with Investigational Medication

Enrolling By Invitation
18 years or above
All
Phase 4
295 participants needed
1 Location

Brief description of study

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 of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: 18 years or above
  • Gender: All

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

This study investigates the long-term safety of an investigational medication known as cilta-cel, which is a type of CAR-T cell therapy. Specifically, cilta-cel targets a protein called B-cell maturation antigen (BCMA) found on certain cancer cells.

Participants in this study will not receive any treatment. Instead, the study will collect data on any delayed side effects that occur after treatment with cilta-cel. This includes checking for adverse events, lab test results, and physical exam findings, including neurological assessments. The study will follow participants for up to 15 years after their last dose of cilta-cel.

  • Who can participate: Participants who have previously received at least one dose of cilta-cel in a company-sponsored study and have provided informed consent are eligible to participate.
  • Study details: Participants will be followed for long-term safety data collection, including annual assessments to monitor any delayed adverse effects.
  • Study timelines: The study will last up to 15 years.
Updated on 28 Jul 2026. Study ID: 21-1484
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