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Study to Compare Mezigdomide, Carfilzomib, and Dexamethasone for Patients with Relapsed or 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 known as Relapsed or Refractory Multiple Myeloma (RRMM), which is a type of cancer that affects plasma cells in the bone marrow. The study is evaluating a new treatment combination that includes the medications Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone. These medications are being tested to see if they can help patients with RRMM who have not responded to previous treatments or whose disease has returned after treatment.

The purpose of the study is to compare the effectiveness of the combination of Mezigdomide, Carfilzomib, and Dexamethasone against the combination of Carfilzomib and Dexamethasone alone. Participants in the study will be randomly assigned to receive either the three-drug combination or the two-drug combination. The study will monitor participants over a period of time to see how long they can live without their disease getting worse, which is known as progression-free survival.

Throughout the study, participants will receive their assigned treatment and will have regular check-ups to monitor their health and the status of their multiple myeloma. The study aims to provide valuable information on whether adding Mezigdomide to the existing treatment can offer better outcomes for patients with RRMM. This research is part of ongoing efforts to find more effective treatments for 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, participants will be randomly assigned to one of two groups. One group will receive a combination of mezigdomide, carfilzomib, and dexamethasone, while the other group will receive only carfilzomib and dexamethasone.

  2. Step 2

    Medication administration

    Participants in the first group will take mezigdomide orally in capsule form. The dosage may vary, including options such as 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg, 0.8 mg, or 1 mg. The specific dosage and frequency will be determined by the study team.

    All participants will receive carfilzomib through an intravenous infusion. The dosage is 60 mg, and the frequency will be specified by the study team.

    Participants will also take dexamethasone orally in capsule form. The dosage and frequency will be determined by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, participants will undergo regular monitoring to assess their health and the effectiveness of the treatment. This will include medical examinations, blood tests, and other necessary evaluations.

    Participants will be required to attend scheduled follow-up visits as determined by the study team to ensure safety and track progress.

  4. Step 4

    Completion of the study

    The study is expected to continue until July 2029. Participants will be informed about the completion of their involvement in the study and any necessary post-study procedures.

Who can join the trial?

7 criteria

  • The participant must have a documented diagnosis of multiple myeloma and measurable disease. This means the disease can be measured in the blood or urine using specific tests.
  • The participant must have received at least one previous treatment for multiple myeloma.
  • The participant must have been treated before with a drug called lenalidomide and a type of medicine known as an anti-CD38 monoclonal antibody.
  • The participant must have shown at least a minimal response to at least one previous treatment for multiple myeloma. A minimal response means the disease showed some improvement.
  • The participant must have experienced disease progression, meaning the disease got worse, during or after their last treatment for multiple myeloma.
  • The participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. This score is used to assess how well a person can perform daily activities. A score of 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but able to do most self-care activities.
  • The study is open to both male and female participants.

Who cannot join the trial?

3 criteria

  • Patients who have not been diagnosed with Relapsed or Refractory Multiple Myeloma (RRMM) cannot participate. This is a type of blood cancer that has returned or does not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to both male and female participants.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Mezigdomide (CC-92480/BMS-986348)

    is a new medication being tested in this study. It is designed to help treat multiple myeloma, a type of blood cancer, especially in patients whose cancer has returned or has not responded to previous treatments. Mezigdomide works by targeting and destroying cancer cells, which may help slow down or stop the progression of the disease.

  • Carfilzomib

    is a medication used to treat multiple myeloma. It works by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting proteasomes, carfilzomib causes a buildup of proteins in cancer cells, leading to their death. This helps to control the growth and spread of the cancer.

  • Dexamethasone

    is a type of steroid medication that is often used in combination with other cancer treatments. It helps reduce inflammation and can also help kill cancer cells. In the context of multiple myeloma, dexamethasone is used to enhance the effectiveness of other treatments and manage symptoms associated with the disease.

What is already known about the treatment

Mezigdomide (CC-92480/BMS-986348) – Mezigdomide is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma, a type of blood cancer. It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for Mezigdomide is to help patients whose multiple myeloma has returned or not responded to previous treatments. At the molecular level, Mezigdomide works by targeting and degrading specific proteins within cancer cells, which can help stop the growth and spread of these cells. It is classified as an immunomodulatory drug, which means it helps to modify the immune system's response to cancer.

Investigated diseases

Relapsed or Refractory 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 relapsed or refractory multiple myeloma, the disease has returned after treatment or does not respond to therapy. The disease progresses as abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and weakened immune function. Over time, these cancerous cells crowd out healthy blood cells, causing anemia and increased risk of infections. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The progression of the disease can vary, with periods of stability followed by worsening symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500861-29-00Protocol codeCA057-008Estimated enrolment506 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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