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Study of JNJ-68284528 for Treating Multiple Myeloma in Patients Using Ciltacabtagene Autoleucel and Drug Combination

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 studying Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is testing a treatment called JNJ-68284528, which is a type of therapy known as Chimeric Antigen Receptor T cell (CAR-T) Therapy. This therapy is designed to target a specific protein called BCMA on the surface of myeloma cells. The goal of the study is to evaluate how well this treatment works in reducing the presence of cancer cells in the body.

Participants in the study will receive the treatment JNJ-68284528 and will be monitored over a period of time to assess the treatment's effectiveness. The study will involve regular check-ups and tests to track the progress of the disease and the response to the treatment. The treatment is administered through an infusion, which means it is given directly into the bloodstream.

In addition to JNJ-68284528, other medications may be used in the study, including Lenalidomide, Dexamethasone, Bortezomib, Fludarabine, Cyclophosphamide, and Daratumumab. These medications are commonly used in the treatment of multiple myeloma and may be given in combination with the main study treatment. The study aims to provide valuable information on the effectiveness of this new therapy in treating multiple myeloma.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Tests may include blood tests, imaging studies, and other evaluations to establish a baseline for the study.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves the administration of lenalidomide and dexamethasone. Lenalidomide is taken orally in capsule form, with dosages varying between 5 mg to 25 mg, depending on the specific protocol.

    Dexamethasone is also taken orally in tablet form, with a typical dosage of 2 mg or 4 mg. The frequency and duration of administration are determined by the study protocol.

  3. Step 3

    Treatment phase 2

    In the second phase, additional medications such as bortezomib and daratumumab may be introduced. Bortezomib is administered subcutaneously, while daratumumab is given intravenously.

    The specific combination and schedule of these medications depend on the cohort and individual response to treatment.

  4. Step 4

    Treatment phase 3

    The third phase may involve the use of ciltacabtagene autoleucel, a specialized therapy administered intravenously. This phase is designed to target specific cancer cells more effectively.

    Monitoring and adjustments to the treatment plan are made based on the patient's response and any side effects experienced.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's health and response to the treatment. This includes physical exams, blood tests, and imaging studies.

    The goal is to evaluate the minimal residual disease (MRD) negative rate, which indicates the effectiveness of the treatment in reducing cancer cells.

  6. Step 6

    End of study

    Upon completion of the study, a final assessment is conducted to determine the overall outcome and any long-term effects of the treatment.

    Patients may receive recommendations for ongoing care or additional treatments based on the results of the study.

Who can join the trial?

13 criteria

  • The study is for patients with a condition called Multiple Myeloma.
  • Participants can be both men and women.
  • Participants must be adults, as the study is for age groups 3 and 4, which typically means adults.
  • Participants must have a measurable disease, which means the disease can be detected and measured using tests.
  • Participants must have had certain treatments before, depending on the group they are in:
  • Cohort A: 1 to 3 previous treatments, including specific types of drugs called PI and IMiD. They should have been resistant to a drug called Lenalidomide.
  • Cohort B: First-time treatment with specific drugs, and they can be patients who have or have not had a transplant.
  • Cohort C: Previously treated with specific drugs and therapies, and the disease must have progressed within a certain time frame.
  • Cohort D: Newly diagnosed with Multiple Myeloma and have had 4 to 8 cycles of initial therapy, including a transplant.
  • Cohort E: Must have a documented diagnosis of Multiple Myeloma.
  • Cohort F: Newly diagnosed with Multiple Myeloma, classified as standard risk, and must have received initial therapy with specific drug combinations.
  • Participants must follow specific guidelines for contraception if they are of childbearing potential.
  • Participants must have a good performance status, meaning they are able to carry out daily activities with little or no assistance.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Multiple Myeloma cannot participate. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not part of the specified clinical trial groups cannot participate. These groups are usually defined by the study based on certain characteristics.
  • Patients who are not female or male cannot participate, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.
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Investigated drugs

JNJ-68284528 is a type of therapy known as CAR-T cell therapy. It is designed to treat multiple myeloma, a type of blood cancer. This therapy involves modifying a patient's own T cells, which are a part of the immune system, to better recognize and attack cancer cells. The modified T cells are directed against a specific protein called BCMA, which is found on the surface of multiple myeloma cells. The goal of this therapy is to help the immune system target and destroy the cancer cells more effectively.

What is already known about the treatment

JNJ-68284528 – This medication is administered as a chimeric antigen receptor T cell (CAR-T) therapy, specifically targeting the BCMA protein found on the surface of multiple myeloma cells. It is currently in Phase 2 clinical trials, with ongoing research to determine its effectiveness and safety. The main therapeutic indication for JNJ-68284528 is the treatment of multiple myeloma, a type of blood cancer. At the molecular level, the therapy works by genetically modifying a patient's T cells to recognize and attack cancer cells expressing the BCMA antigen. It falls under the pharmacological classification of immunotherapy, utilizing the body's immune system to combat 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. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to symptoms such as bone pain, frequent infections, and anemia. As the disease progresses, it can cause damage to bones and kidneys, and lead to high levels of calcium in the blood. The abnormal plasma cells produce a protein that can be detected in the blood or urine, which helps in monitoring the disease. Over time, the accumulation of these proteins can cause organ damage, particularly to the kidneys. The progression of Multiple Myeloma can vary, with periods of stability followed by active disease phases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506587-13-00Estimated enrolment170 patientsSponsorJanssen Cilag International

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