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Study Comparing BMS-986393 CAR T Cell Therapy to Standard Treatments for Adults with Relapsed or Refractory Multiple Myeloma Resistant to Lenalidomide

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 treatment for Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study is specifically for patients whose disease has returned or has not responded to previous treatments, including a medication called Lenalidomide. The main treatment being tested is a new type of therapy called BMS-986393, also known as GPRC5D-directed CAR T Cell Therapy. This therapy involves using a patient's own T-cells, which are a type of immune cell, that have been modified to better recognize and attack cancer cells. The study will compare this new treatment to standard treatments, which include combinations of drugs like Daratumumab, Pomalidomide, and Dexamethasone, or Carfilzomib with Dexamethasone.

The purpose of the study is to determine if the new therapy works better than the standard treatments. Participants will receive either the new therapy or one of the standard treatments. The study will monitor how long participants live without their cancer getting worse and whether they achieve a state where no signs of cancer can be found in their body. The study will also look at overall survival, which is the average time participants are alive after starting the study, and how many participants show a positive response to the treatment.

Participants in the study will be adults who have received 1-3 previous treatments for Multiple Myeloma and have evidence that their disease worsened during or after their last treatment. The study will take place over several years, with an estimated end date in 2032. The goal is to find out if the new therapy can provide better outcomes for patients with this challenging condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be assigned to one of two groups. One group will receive the new treatment called BMS-986393, a type of therapy that uses your own cells to fight the disease. The other group will receive standard treatments, which may include a combination of medications such as daratumumab, pomalidomide, and dexamethasone or carfilzomib with dexamethasone.

  2. Step 2

    Treatment administration

    If you are in the group receiving BMS-986393, the treatment will be given through an intravenous infusion, which means it will be delivered directly into your bloodstream through a vein. This process involves collecting your cells, modifying them in a laboratory, and then infusing them back into your body.

    If you are in the standard treatment group, you will receive medications as follows: daratumumab is given as a subcutaneous injection, pomalidomide is taken orally, and dexamethasone is taken orally or intravenously. Carfilzomib is administered intravenously.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular check-ups will be conducted to monitor your health and the effectiveness of the treatment. This includes blood tests, imaging tests, and other assessments as needed.

    The study aims to measure how long you live without the disease getting worse and whether there are no signs of the disease in your body after treatment.

  4. Step 4

    End of study participation

    Your participation in the study will continue until the study ends or until it is determined that the treatment is no longer beneficial for you. The estimated end date for the study is June 21, 2032.

Who can join the trial?

5 criteria

  • Have Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (RRMM). This means the multiple myeloma has returned or did not respond to previous treatments, including a specific drug called Lenalidomide.
  • Have received 1-3 previous treatments for multiple myeloma, and the disease got worse during or after the last treatment.
  • Have measurable signs of multiple myeloma according to the study's criteria.
  • Be at least 18 years old.
  • Have adequate organ function and performance status as per the study's criteria. This means your organs are working well enough, and you are physically able to participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who have not experienced a return or worsening of their Multiple Myeloma after treatment with Lenalidomide cannot participate. Multiple Myeloma is a type of blood cancer, and Lenalidomide is a medication used to treat it.
  • Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups.
  • Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.
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Investigated drugs

  • BMS-986393

    is a type of therapy called CAR-T cell therapy. This treatment involves taking some of your own immune cells, changing them in a lab to better fight cancer, and then putting them back into your body. The goal is to help your immune system find and destroy cancer cells more effectively.

  • Daratumumab

    is a medication used to treat multiple myeloma, a type of blood cancer. It works by attaching to a specific protein on the surface of cancer cells, helping your immune system to find and kill these cells.

  • Pomalidomide

    is a medication that helps your immune system fight cancer. It works by stopping the growth of cancer cells and helping your body’s natural defenses to attack the cancer.

  • Dexamethasone

    is a type of steroid that helps reduce inflammation and can also help kill cancer cells. It is often used in combination with other cancer treatments to improve their effectiveness.

  • Carfilzomib

    is a medication used to treat multiple myeloma. It works by blocking the action of certain proteins in cancer cells, which can help stop the growth and spread of the cancer.

What is already known about the treatment

BMS-986393 – This medication is administered as a CAR-T cell therapy, which involves modifying a patient's own immune cells to better recognize and attack cancer cells. It is currently being studied in clinical trials for its effectiveness in treating adults with multiple myeloma that has returned or is resistant to other treatments, specifically those who have not responded to lenalidomide. The main goal of the trial is to determine if BMS-986393 is more effective than standard treatments, such as Daratumumab with Pomalidomide and Dexamethasone or Carfilzomib with Dexamethasone. At the molecular level, BMS-986393 targets a specific protein on cancer cells, helping the immune system to identify and destroy these cells. It is classified as a type of immunotherapy, which is a treatment that uses the body's own immune system to fight cancer.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of abnormal cells can lead to anemia and increased calcium levels in the blood. The disease often goes through periods of remission and relapse, where symptoms may improve and then worsen again.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515279-37-00Protocol codeCA088-1007Estimated enrolment440 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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