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Study of iberdomide alone or with drug combinations for patients with multiple myeloma: testing safety and effectiveness of different doses

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies Multiple Myeloma, a type of blood cancer affecting plasma cells in the bone marrow. The study evaluates a new drug called iberdomide (also known as CC-220) both alone and in combination with other established treatments including dexamethasone and daratumumab. The purpose is to determine the highest safe dose of iberdomide and to assess how well it works in treating patients whose cancer has returned or did not respond to previous treatments.

The treatment involves taking iberdomide capsules by mouth, either alone or together with other medications. Some participants will receive dexamethasone tablets orally, while others may also receive daratumumab as an injection under the skin. The study has multiple parts to test different drug combinations and doses.

The researchers will monitor how patients respond to the treatment by measuring changes in their cancer, tracking side effects, and studying how the body processes the medication. They will also look at how long the treatment keeps the cancer under control and how long patients survive after starting treatment. The study is expected to continue until early 2028.

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 Treatment Phase

    You will receive iberdomide in capsule form, taken by mouth daily

    Treatment will be given in combination with dexamethasone tablets, also taken by mouth

    Some patients will additionally receive daratumumab as an injection under the skin

  2. Step 2

    Monitoring Period

    Regular assessments will track your response to treatment

    Blood tests will be performed to measure the levels of medications in your system

    Your multiple myeloma status will be evaluated using standard medical tests

  3. Step 3

    Response Evaluation

    Your response to treatment will be measured according to standard criteria for multiple myeloma

    The effectiveness of the treatment will be assessed through regular medical examinations

    The time between starting treatment and seeing initial results will be tracked

  4. Step 4

    Long-term Follow-up

    Your progress will be monitored until February 2028

    Regular assessments will continue to track your health status

    Any side effects will be documented throughout the treatment period

  5. Step 5

    Safety Monitoring

    Side effects will be monitored and documented throughout the study

    The severity and frequency of any health changes will be recorded

    Your overall health status will be regularly assessed

Who can join the trial?

11 criteria

  • Must be 18 years or older at the time of signing the informed consent form
  • Must have an ECOG performance status of 0, 1, or 2 (a measure of a patient's ability to perform daily activities)
  • Must have a confirmed diagnosis of Multiple Myeloma with measurable disease levels: - Blood protein level of at least 0.5 g/dL, or - Urine protein level of at least 200 mg/24 hours, or - Light chain levels of at least 10 mg/dL with abnormal blood protein ratios
  • Must have received at least 2 prior treatment regimens for myeloma (for most study groups) or at least 3 prior treatments for specific groups
  • Must have previously received at least 2 cycles of treatment with: - Lenalidomide or pomalidomide - A proteasome inhibitor - A CD38 antibody (for certain study groups)
  • Must show disease progression within 60 days from the last treatment
  • Must agree to follow all requirements of the Pregnancy Prevention Program
  • Must not donate blood during treatment and for 28 days after the last dose
  • Male participants must not donate sperm during treatment and for 90 days after the last dose
  • Must be willing to follow the study schedule and requirements
  • Must sign an informed consent form before starting any study procedures

Who cannot join the trial?

14 criteria

  • Prior treatment with CC-220 (an experimental drug for multiple myeloma)
  • Known allergic reactions or hypersensitivity to any components of the study medications
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Other types of cancer within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
  • Significant heart problems, including heart failure or recent heart attack
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or requiring dialysis
  • Blood clotting disorders or history of blood clots
  • Pregnancy or breastfeeding
  • Mental health conditions that could interfere with following study procedures
  • Taking medications that could interact with the study drugs
  • Participation in other clinical trials within the past 28 days
  • Unable to take blood-thinning medications if required during the study
  • History of severe allergic reactions to injectable medications
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Investigated drugs

  • CC-220

    is an experimental medication being studied for the treatment of multiple myeloma. It is being tested both alone and in combination with other medications.

  • Dexamethasone (DEX)

    is a steroid medication that helps reduce inflammation and suppress the immune system. It is commonly used in the treatment of multiple myeloma and other cancers.

  • Daratumumab (DARA)

    is a targeted therapy that works by helping the immune system attack cancer cells. It is specifically designed to treat multiple myeloma.

  • Bortezomib (BTZ)

    is a targeted therapy that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins that help cancer cells survive and multiply.

  • Carfilzomib (CFZ)

    is also a proteasome inhibitor that works similarly to bortezomib. It is used in the treatment of multiple myeloma when other treatments have not been effective.

What is already known about the treatment

  • CC-220

    An investigational oral immunomodulatory drug being studied in clinical trials for the treatment of Multiple Myeloma. This medication is being evaluated both as monotherapy and in combination with dexamethasone, daratumumab, bortezomib, or carfilzomib for patients with relapsed/refractory multiple myeloma. The drug belongs to the class of immunomodulatory agents and works by modifying the immune system's response to cancer cells.

  • Dexamethasone (DEX)

    A synthetic corticosteroid medication administered orally or by injection, commonly used in combination therapy for multiple myeloma. It works by reducing inflammation and suppressing the immune system, helping to control cancer cell growth and manage symptoms. The drug is well-established in medical literature and is a standard component of many multiple myeloma treatment regimens.

  • Daratumumab (DARA)

    A targeted monoclonal antibody therapy administered through intravenous infusion for treating multiple myeloma. It works by binding to a specific protein (CD38) found on myeloma cells, helping the immune system identify and destroy these cancer cells. The medication is approved for use in various combination therapies for multiple myeloma treatment.

  • Bortezomib (BTZ)

    A proteasome inhibitor administered either intravenously or subcutaneously for the treatment of multiple myeloma. It works by blocking the proteasome, a cellular complex that breaks down proteins, leading to the accumulation of proteins in cancer cells and causing them to die. The drug is well-established in medical practice and is commonly used in combination therapy for multiple myeloma.

  • Carfilzomib (CFZ)

    A second-generation proteasome inhibitor administered intravenously for treating multiple myeloma. Like bortezomib, it works by blocking protein breakdown in cancer cells, but with potentially different side effect profiles and efficacy patterns. The medication is approved for use in combination therapy for patients with relapsed or refractory multiple myeloma.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancer cells produce large amounts of abnormal proteins instead of useful antibodies. The disease causes bones to weaken, leading to bone pain and increased risk of fractures. Multiple myeloma can also affect the body's ability to make healthy blood cells, potentially leading to anemia and increased infections.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-510799-19-00Protocol codeCC-220-MM-001Estimated enrolment498 patientsSponsorCelgene Corp.

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