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Long-term Safety Study of Ciltacabtagene Autoleucel for Patients with Multiple Myeloma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on the long-term follow-up of participants who have been previously treated for Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The treatment being studied is called Ciltacabtagene Autoleucel, also known by its code name JNJ-68284528. This treatment is a form of cell therapy where a patient's own T-cells, a type of immune cell, are genetically modified to better recognize and attack cancer cells. The modified cells are then infused back into the patient.

The purpose of this study is to gather information on any delayed side effects that may occur after receiving Ciltacabtagene Autoleucel and to understand its long-term safety. Participants in this study have already received this treatment in a previous clinical trial. The study will monitor for any new or worsening health issues, such as new cancers, neurological disorders, or autoimmune conditions, over an extended period. It will also track the overall survival of participants and the long-term effectiveness of the therapy.

Throughout the study, participants will have regular check-ups to assess their health and any potential side effects. The study aims to provide valuable insights into the long-term impact of this innovative treatment for Multiple Myeloma, helping to ensure its safety and effectiveness for future patients. The study is expected to continue for several years to gather comprehensive data on the participants' health outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after receiving at least one dose of ciltacabtagene autoleucel in a previous clinical study.

    Informed consent is required to participate in this long-term follow-up study.

  2. Step 2

    Treatment overview

    The study involves monitoring after the administration of ciltacabtagene autoleucel, a treatment for multiple myeloma.

    The medication is administered as a dispersion for infusion through intravenous use.

  3. Step 3

    Monitoring period

    The study aims to collect data on delayed adverse events and to understand the long-term safety profile of the treatment.

    Monitoring includes checking for new or worsening conditions such as malignancies, neurologic disorders, autoimmune disorders, and serious infections.

  4. Step 4

    Adverse event tracking

    Adverse events are tracked over different timeframes: Years 1-5 and Years 6-15.

    Events include new malignancies, neurologic disorders, autoimmune disorders, and serious infections.

  5. Step 5

    Secondary assessments

    Secondary assessments include measuring specific markers in the blood and evaluating the long-term efficacy of the therapy.

    Overall survival is also assessed as part of the study.

  6. Step 6

    Study duration

    The study is expected to continue until May 31, 2042.

    Participants will be monitored throughout this period to gather comprehensive long-term data.

Who can join the trial?

5 criteria

  • The patient must have received at least one dose of **cilta-cel** in a previous clinical study sponsored by the Company. **Cilta-cel** is a type of treatment used in certain medical studies.
  • The patient must have given their agreement, known as **informed consent**, to participate in this study. **Informed consent** means the patient understands the study and agrees to take part.
  • Both male and female patients are eligible to participate.
  • The study includes patients from different age groups, specifically those who are adults.
  • The study may include patients who are considered part of a **vulnerable population**. This term refers to groups of people who might need special protection or care.
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Investigated drugs

Ciltacabtagene Autoleucel is a type of therapy used in the clinical trial. It is a form of CAR-T cell therapy, which involves modifying a patient's own immune cells to better recognize and attack cancer cells. This therapy is specifically designed to target certain proteins found on the surface of cancer cells, helping the immune system to fight the cancer more effectively. The trial aims to monitor the long-term safety and any delayed side effects of this treatment.

What is already known about the treatment

Ciltacabtagene Autoleucel – This medication is administered as an infusion, typically in a hospital setting. It is currently being studied in clinical trials, particularly for its long-term effects and safety profile. The main therapeutic indication for Ciltacabtagene Autoleucel is the treatment of multiple myeloma, a type of blood cancer. At the molecular level, it works by modifying a patient's own T-cells to recognize and attack cancer cells. It is classified as a CAR-T cell therapy, which is a type of immunotherapy designed to enhance the body's immune response against cancer.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to the formation of tumors in the bones or soft tissues. Over time, the disease can cause significant complications, including kidney dysfunction and severe bone damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505530-10-00Protocol code68284528MMY4002Estimated enrolment392 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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