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Study Comparing Mezigdomide, Bortezomib, and Dexamethasone with Pomalidomide, Bortezomib, 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 Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is specifically looking at cases where the disease has either returned after treatment or has not responded to previous treatments, referred to as Relapsed or Refractory Multiple Myeloma. The trial aims to compare the safety and effectiveness of two different treatment combinations. One combination includes the medication Mezigdomide (also known by its code name CC-92480), along with Bortezomib and Dexamethasone. The other combination involves Pomalidomide (also known as CC-4047), together with Bortezomib and Dexamethasone.

The purpose of the study is to determine which treatment combination is more effective in managing the disease. Participants in the trial will be randomly assigned to receive one of the two treatment combinations. The study will monitor the participants over a period to observe how the disease progresses and to assess the safety of the treatments. The trial will also look at various outcomes, such as how long the disease remains under control, the overall survival of participants, and the quality of life during the treatment.

Throughout the study, participants will receive their assigned treatment and will be regularly checked by healthcare professionals to monitor their health and the effects of the treatment. The trial is designed to gather important information that could help improve treatment options for people with Multiple Myeloma in the future. Participants will be closely observed to ensure their safety and to collect data on how well the treatments work in controlling the disease.

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.

    The assessment ensures that the patient has a documented diagnosis of multiple myeloma and meets specific health criteria.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two treatment groups. This process is essential to compare the effectiveness of the two treatment regimens.

  3. Step 3

    Treatment phase

    The patient receives one of the following treatment combinations:

    Group 1: Mezigdomide (CC-92480), Bortezomib, and Dexamethasone.

    Group 2: Pomalidomide, Bortezomib, and Dexamethasone.

    Medications are administered as follows:

    Mezigdomide and Pomalidomide are taken orally in capsule form. Dosages vary based on the specific medication and patient needs.

    Bortezomib is administered as a subcutaneous injection.

    Dexamethasone is taken orally in tablet form or administered intravenously as a solution for injection.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the patient's response to treatment and any side effects.

    This includes routine blood tests, imaging studies, and health assessments.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation is performed to determine the effectiveness of the treatment.

    This includes measuring progression-free survival and other health outcomes.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of **Multiple Myeloma** and measurable disease. This means that certain proteins in the blood or urine are at specific levels, or there are abnormal levels of certain light chains in the blood.
  • The patient should have received 1 to 3 previous treatments for **Multiple Myeloma**.
  • The patient must have been treated with a medication regimen that included **lenalidomide** in the past.
  • The patient must have shown at least a minimal improvement in their condition from at least one previous treatment for **Multiple Myeloma**.
  • The patient must have experienced a worsening of their disease during or after their last treatment for **Multiple Myeloma**.
  • The patient must have an **ECOG performance status** score of 0, 1, or 2. This score is a way to measure how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Both male and female patients are eligible to participate.
  • The study includes patients who may be considered vulnerable, meaning they might need extra care or protection.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than relapsed or refractory multiple myeloma cannot participate. This means the study is only for those whose multiple myeloma has returned or did not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have certain other health conditions that might interfere with the study cannot participate. This is to ensure the safety of the participants and the accuracy of the study results.
  • Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
  • Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the study results.
  • Patients who have allergies or reactions to the study medications cannot participate. This is to prevent any harmful effects.
  • Patients who have not recovered from previous treatments or surgeries may not be eligible. This is to ensure participants are in a stable condition before starting the study.
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Investigated drugs

  • Mezigdomide (CC-92480)

    is an experimental medication being tested for its effectiveness in treating multiple myeloma, a type of blood cancer. It is being studied to see if it can help stop the cancer from growing or spreading in patients whose cancer has returned or did not respond to previous treatments.

  • Bortezomib

    is a medication used to treat multiple myeloma. It works by interfering with the growth of cancer cells, which are eventually destroyed. It is often used in combination with other medications to enhance its effectiveness.

  • Dexamethasone

    is a type of steroid medication that helps reduce inflammation and suppress the immune system. In the context of multiple myeloma, it is used to help control the symptoms and improve the effectiveness of other cancer treatments.

  • Pomalidomide

    is a medication used to treat multiple myeloma, especially in patients who have not responded to other treatments. It works by helping the immune system attack cancer cells and by stopping the growth of these cells.

What is already known about the treatment

  • Mezigdomide

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma. It is not yet widely used in standard medical practice, as it is still under investigation. Mezigdomide works by modulating the immune system to target and destroy cancer cells. It belongs to a class of drugs known as immunomodulatory agents.

  • Bortezomib

    This medication is administered via injection and is an established treatment for multiple myeloma, including relapsed or refractory cases. It is widely recognized in medical literature and is used to inhibit the proteasome, a complex that breaks down proteins in cells, leading to cancer cell death. Bortezomib is classified as a proteasome inhibitor.

  • Dexamethasone

    This medication is taken orally or by injection and is commonly used in combination with other drugs to treat multiple myeloma. It is well-documented in medical literature and works by reducing inflammation and suppressing the immune response. Dexamethasone is classified as a corticosteroid.

  • Pomalidomide

    This medication is administered orally and is used in the treatment of relapsed or refractory multiple myeloma. It is recognized in medical literature and works by enhancing the immune system's ability to fight cancer cells. Pomalidomide is classified as an immunomodulatory agent.

Investigated diseases

Relapsed or 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 cancer has either returned after treatment (relapsed) or has not responded to treatment (refractory). It typically leads to an overproduction of abnormal plasma cells, which can crowd out healthy blood cells. This can result in symptoms such as bone pain, anemia, kidney problems, and increased risk of infections. The disease progresses as these abnormal cells continue to multiply, potentially causing damage to bones and other organs. Managing the progression of this disease often involves monitoring and adjusting treatment strategies to control the growth of cancerous cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509859-13-00Protocol codeCA057-001Estimated enrolment901 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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