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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Lille Lille France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Universitair Ziekenhuis Gent Gent Belgium
Hopital Beaujon Clichy France
Uazzdxzahxln Mlddorl Cyeaaxv Golefyecy Groningen The Netherlands
Apymffvao Uow Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
17.02.2022
France France
Recruiting
17.02.2022
Spain Spain
Recruiting
17.02.2022
The Netherlands The Netherlands
Recruiting
17.02.2022

Trial locations

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.

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 ID:
2023-505530-10-00
Protocol code:
68284528MMY4002
NCT ID:
NCT05201781
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

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