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Study on Mezigdomide, Carfilzomib, and Dexamethasone for Patients with Relapsed, Refractory, or Newly Diagnosed 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 multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves patients with both relapsed or refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The main purpose of the study is to determine the best dose and schedule, as well as to evaluate the safety and initial effectiveness of a new treatment called mezigdomide, which is being tested in combination with standard treatments.

The study will use several medications, including Kyprolis (carfilzomib), Dexamethasone, CC-92480 (mezigdomide), Darzalex (daratumumab), Velcade (bortezomib), and Empliciti (elotuzumab). These medications are administered in different forms such as tablets, capsules, and solutions for injection or infusion. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

Participants in the study will receive these treatments over a period of time, and their health will be closely monitored to assess how well the treatment works and to identify any side effects. The study aims to find the most effective and safe way to use mezigdomide in combination with other treatments for multiple myeloma. The trial is expected to continue until 2026, with ongoing assessments of participants' responses to the treatment.

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

    Joining the study

    Upon joining the study, the patient will be required to sign an informed consent form. This confirms understanding and agreement to participate in the trial.

    The patient must be at least 18 years old and meet specific health criteria, including a performance status score of 0, 1, or 2, which measures the ability to perform daily activities.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the patient's health status and eligibility for the trial. This may include physical examinations and laboratory tests.

  3. Step 3

    Treatment phase

    The treatment phase involves administering a combination of medications. The main medication being tested is mezigdomide, which is given in combination with standard treatments for multiple myeloma.

    Medications include carfilzomib (Kyprolis) administered intravenously, dexamethasone taken orally, and mezigdomide in capsule form. Other medications like daratumumab (Darzalex) and bortezomib (Velcade) may be administered subcutaneously or intravenously.

    The dosage and frequency of these medications will be determined based on the specific treatment regimen assigned to the patient.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient's response to treatment will be closely monitored. This includes regular visits to the study site for assessments and tests.

    The primary focus is to determine the recommended dose and regimen of mezigdomide and evaluate its safety and effectiveness when combined with other treatments.

  5. Step 5

    Completion of the trial

    Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall response to the treatment.

    The trial aims to measure outcomes such as the time to response, duration of response, and overall response rate.

Who can join the trial?

10 criteria

  • The person must be at least 18 years old when they sign the consent form.
  • The person must understand and willingly sign a consent form before any study-related activities begin.
  • The person must be willing and able to follow the study visit schedule and other study requirements.
  • The person must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. This score is a way to measure how well a person can perform daily activities.
  • Females who can have children must agree to follow all testing and birth control requirements as outlined in the mezigdomide Global Pregnancy Prevention Plan (PPP). The duration of birth control depends on the specific treatment they receive.
  • Male participants must agree to follow all requirements in the mezigdomide Global PPP. The duration of birth control depends on the specific treatment they receive, even if they have had a successful vasectomy.
  • Male participants must agree not to donate sperm or semen for a certain period after their last dose of treatment, as specified in the mezigdomide Global PPP.
  • Females must agree not to donate egg cells (ova) as specified in the mezigdomide Global PPP.
  • All participants must agree not to donate blood while receiving study treatment and for 28 days after the last dose of study treatment.
  • All male and female participants must follow all other requirements defined in the mezigdomide Global PPP.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than **multiple myeloma** cannot participate. **Multiple myeloma** is a type of cancer that affects certain blood cells in the bone marrow.
  • Patients who are not diagnosed with **relapsed or refractory multiple myeloma (RRMM)** or **newly diagnosed multiple myeloma (NDMM)** are excluded. **Relapsed** means the cancer has returned after treatment, and **refractory** means the cancer does not respond to treatment.
  • Patients who are under the age of 18 cannot participate in the study.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
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Investigated drugs

Mezigdomide is a medication being studied for its potential to treat multiple myeloma, a type of blood cancer. In this clinical trial, researchers are testing mezigdomide in combination with other standard treatments to find the best dose and to see how safe and effective it is for patients who have either relapsed or refractory multiple myeloma, as well as those who are newly diagnosed.

What is already known about the treatment

Mezigdomide – Mezigdomide is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). It is in the investigational stage, with ongoing research to determine its optimal dosage and safety profile. The medication works by modulating the immune system and targeting specific proteins involved in the growth and survival of cancer cells. Mezigdomide is classified as an immunomodulatory drug, which means it helps regulate the immune response 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 bone damage, kidney problems, and a weakened immune system. The disease can be classified into different stages, with symptoms ranging from bone pain and fatigue to more severe complications as it progresses. Relapsed or refractory multiple myeloma refers to cases where the disease returns after treatment or does not respond to standard therapies. Newly diagnosed multiple myeloma indicates the initial identification of the disease in a patient. The progression of multiple myeloma can vary, with some patients experiencing slow development while others may have a more aggressive form.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505219-19-00Protocol codeCC-92480-MM-002Estimated enrolment190 patientsSponsorCelgene Corp.

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