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Study Comparing Ciltacabtagene Autoleucel with Pomalidomide, Bortezomib, and Dexamethasone for Patients with Relapsed and Lenalidomide-Refractory 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 studying a condition called Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study is specifically looking at patients whose disease has returned after treatment and who are resistant to a medication called Lenalidomide. The trial will compare the effectiveness of a new treatment called JNJ-68284528, also known as a CAR-T cell therapy, against two standard treatment combinations. One combination includes Pomalidomide, Bortezomib, and Dexamethasone (referred to as PVd), and the other includes Daratumumab, Pomalidomide, and Dexamethasone (referred to as DPd).

The purpose of the study is to see how well the new CAR-T cell therapy works compared to the standard treatments. CAR-T cell therapy is a type of treatment where a patient's own immune cells are modified in a lab to better fight cancer cells. The study will involve participants receiving either the new therapy or one of the standard treatment combinations. The trial will monitor the participants over a period to see which treatment helps in delaying the progression of the disease.

Participants in the study will be randomly assigned to receive either the new CAR-T cell therapy or one of the standard treatment combinations. The study will take place over several months, and participants will be closely monitored by healthcare professionals. The goal is to determine which treatment is more effective in managing relapsed and resistant Multiple Myeloma. This research could potentially lead to new treatment options for patients with this challenging condition.

The research process

The trial runs in 5 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 reviewing medical history and current health status.

    Eligibility criteria include being at least 18 years old, having a documented diagnosis of multiple myeloma, and having received 1 to 3 prior lines of therapy.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups: either the CAR-T therapy group or one of the standard therapy groups.

    The standard therapy groups include either a combination of pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

  3. Step 3

    Treatment administration

    For the CAR-T therapy group, the treatment involves cilta-cel, a chimeric antigen receptor T cell therapy directed against BCMA.

    For the PVd group, the treatment includes pomalidomide (oral capsules), bortezomib (subcutaneous injection), and dexamethasone (oral tablets).

    For the DPd group, the treatment includes daratumumab (subcutaneous injection), pomalidomide (oral capsules), and dexamethasone (oral tablets).

  4. Step 4

    Monitoring and follow-up

    Participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes routine health checks and laboratory tests.

    Progression-free survival (PFS) is the primary endpoint being measured, which refers to the length of time during and after treatment that the patient lives without the disease worsening.

  5. Step 5

    Study completion

    The study is estimated to conclude by June 2027. Participants will continue to be monitored until the study's end date or until they meet the criteria for discontinuation.

Who can join the trial?

9 criteria

  • Be at least 18 years old.
  • Have a confirmed diagnosis of Multiple Myeloma. This is a type of cancer that affects certain blood cells.
  • Have a measurable disease at the time of screening. This means the disease can be measured or tracked by doctors.
  • Have received 1 to 3 previous treatments, including a PI (Proteasome Inhibitor) and IMiD (Immunomodulatory Drug). You must have completed at least one full cycle of treatment for each therapy, unless the disease got worse during the treatment.
  • Have proof that the disease has gotten worse, according to specific criteria, within 6 months of the last treatment.
  • If you have had only one previous treatment, the disease must have gotten worse within 36 months after a stem cell transplant (a procedure to replace damaged blood cells) or within 42 months of starting the first treatment if no transplant was done.
  • Be refractory to lenalidomide, meaning the disease did not respond to this drug in at least one previous treatment.
  • Have an ECOG Performance Status score of 0 or 1. This is a scale used to assess how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Have certain clinical laboratory values as specified in the study protocol.

Who cannot join the trial?

5 criteria

  • Patients who have not experienced a return of their disease after treatment, known as relapsed, or whose disease does not respond to the drug Lenalidomide, referred to as Lenalidomide-Refractory.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specific clinical trial group being studied.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

  • JNJ-68284528

    This is a type of therapy known as CAR-T cell therapy. It involves modifying a patient's own T cells to better recognize and attack cancer cells. In this trial, it is directed against a specific protein found on multiple myeloma cells called BCMA. The goal is to help the immune system target and destroy these cancer cells more effectively.

  • Pomalidomide

    This medication is used to treat multiple myeloma by helping the immune system attack cancer cells and by stopping the growth of these cells. It is often used in combination with other drugs to enhance its effectiveness.

  • Bortezomib

    This is a type of medication known as a proteasome inhibitor. It works by interfering with the cancer cells' ability to break down proteins, which leads to cell death. It is used in combination with other medications to treat multiple myeloma.

  • Dexamethasone

    This is a corticosteroid medication that helps reduce inflammation and suppresses the immune system. In the context of multiple myeloma, it is used to help control the disease and manage symptoms.

  • Daratumumab

    This is a monoclonal antibody that targets a specific protein on the surface of multiple myeloma cells. By binding to this protein, it helps the immune system identify and destroy the cancer cells. It is used in combination with other treatments to improve outcomes for patients with multiple myeloma.

What is already known about the treatment

Cilta-cel – This medication is administered as a chimeric antigen receptor T cell (CAR-T) therapy, specifically targeting the BCMA protein on multiple myeloma cells. It is currently being studied in clinical trials for its effectiveness in treating relapsed and lenalidomide-refractory multiple myeloma. The main therapeutic indication is for patients who have not responded to previous treatments. Cilta-cel works by genetically modifying a patient's T cells to better recognize and attack cancer cells. It falls under the pharmacological classification of immunotherapy, specifically CAR-T cell therapy.

Investigated diseases

Relapsed and Lenalidomide-Refractory Multiple Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the disease has returned after treatment (relapsed) and does not respond to the drug lenalidomide (refractory). Multiple myeloma causes cancerous plasma cells to accumulate in the bone marrow, leading to bone damage and affecting the production of healthy blood cells. As the disease progresses, patients may experience symptoms such as bone pain, fatigue, and frequent infections. The condition is characterized by cycles of remission and relapse, with each relapse potentially being more challenging to treat.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506588-32-00Protocol code68284528MMY3002Estimated enrolment397 patientsSponsorJanssen Cilag International

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