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Study of ixazomib, iberdomide and dexamethasone combination in elderly patients with first relapse of multiple myeloma

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with Multiple Myeloma, a type of blood cancer affecting plasma cells in the bone marrow. The research evaluates a combination treatment using three medications: Iberdomide, Ixazomib, and Dexamethasone. These medications are taken orally in the form of tablets or capsules. The study specifically looks at elderly patients whose disease has returned after their first treatment.

The treatment combines different doses of Iberdomide (ranging from 0.75 mg to 1.6 mg daily), Ixazomib (up to 3 mg daily), and Dexamethasone (up to 20 mg daily). The purpose of this research is to determine how well patients respond to this combination of medications, particularly in achieving a very good partial response or better to the treatment.

The study will monitor how the medications work together, how well patients tolerate them, and track any side effects that may occur. Patients will be followed for several years to assess both the short-term and long-term effects of the treatment. The study will also look at how long the treatment remains effective and how it affects patients' quality of life.

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 a combination of three medications: Iberdomide, Ixazomib, and Dexamethasone. All medications are taken by mouth.

    The medications come in the following forms:

    - Iberdomide: capsules (available in 0.75mg, 1mg, 1.3mg, or 1.6mg doses)

    - Ixazomib: capsules

    - Dexamethasone: tablets

  2. Step 2

    Response monitoring at 3 months

    Your response to treatment will be evaluated after 3 months of therapy

    The evaluation includes checking how well the multiple myeloma is responding to the treatment

  3. Step 3

    Response monitoring at 6 months

    Another evaluation of your response to treatment will be performed after 6 months of therapy

    This assessment will determine how the disease is responding to the medication combination

  4. Step 4

    Ongoing assessments

    Regular monitoring of side effects throughout the treatment period

    Quality of life assessments using specific questionnaires

    Blood tests to monitor your condition

    The treatment will continue until either the disease progresses or you experience unacceptable side effects

  5. Step 5

    Follow-up period

    After completing or stopping treatment, you will be monitored to track your progress

    The total study duration is planned until June 2028

Who can join the trial?

16 criteria

  • Must be 70 years of age or older
  • Must have a general health status score (ECOG) of 2 or less, which means being able to care for yourself and be up and about more than 50% of waking hours
  • Must have a life expectancy of more than 6 months
  • Must provide written informed consent to participate in the study
  • Must have symptomatic multiple myeloma that has returned after first treatment (first relapse)
  • Must have received at least 3 cycles of one previous treatment
  • Must have measurable disease levels shown by at least one of these tests:
    • Blood protein level of 0.5 g/dL or higher
    • Urine protein level of 200 mg or more in 24 hours
    • Free light chain level of 10 mg/dL or higher with abnormal ratio
    • Must meet specific blood test requirements:
      • Adequate white blood cell count (neutrophils)
      • Adequate platelet count
      • Acceptable liver function tests
      • Adequate kidney function
      • Must follow the study's pregnancy prevention plan
      • For women: must be post-menopausal for at least 24 months or surgically unable to have children
      • For men: must agree to practice complete abstinence or use condoms during treatment and for 90 days after the last dose

Who cannot join the trial?

15 criteria

  • Previous severe allergic reactions to any of the study medications (Iberdomide, Ixazomib, or Dexamethasone)
  • Active or uncontrolled infections that require treatment
  • Pregnancy or breastfeeding
  • Major surgery within 14 days before starting the study
  • Participation in another clinical trial within 28 days before starting this study
  • Serious heart conditions, including:
    • Heart attack within the last 6 months
    • Unstable heart rhythm problems
    • Heart failure with symptoms
    • Severe liver problems
    • Severe kidney problems requiring dialysis (a process to filter blood when kidneys don't work properly)
    • Other types of cancer that require treatment (except for certain skin cancers)
    • Mental health conditions that could interfere with following study procedures
    • Any condition that, in the doctor's opinion, would make participation unsafe
    • Unable to take oral medications
    • Known HIV, active hepatitis B, or active hepatitis C infection
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Investigated drugs

  • Iberdomide

    is a medication that works by helping to regulate the immune system and fight cancer cells. It belongs to a class of drugs called immunomodulators, which are commonly used in the treatment of multiple myeloma.

  • Ixazomib

    is an oral medication that belongs to a group of drugs called proteasome inhibitors. It works by blocking certain proteins in cancer cells, which helps to slow or stop the growth of these cells. It is specifically designed to treat multiple myeloma.

  • Dexamethasone

    is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it is often used in combination with other medications to enhance their effectiveness and manage certain side effects of treatment.

What is already known about the treatment

  • Iberdomide

    An oral medication used in clinical trials for treating multiple myeloma, particularly in elderly patients who have experienced their first relapse. It belongs to the class of immunomodulatory drugs (IMiDs) that work by modifying the immune system's response and inhibiting cancer cell growth. The medication is currently being studied in combination with Ixazomib and Dexamethasone as part of a phase 2 clinical trial protocol.

  • Ixazomib

    An oral proteasome inhibitor medication used in the treatment of multiple myeloma, particularly for patients who have received previous treatments. It works by blocking certain proteins in cancer cells that break down other proteins, leading to cancer cell death. This medication represents a significant advancement in myeloma treatment as it was the first oral proteasome inhibitor approved for clinical use.

  • Dexamethasone

    An oral or injectable corticosteroid medication commonly used in combination with other drugs for treating multiple myeloma and various inflammatory conditions. It works by suppressing the immune system and reducing inflammation throughout the body, making it an effective component in cancer treatment protocols. The medication is well-established in medical practice and is frequently used as part of combination therapy in multiple myeloma treatment.

Investigated diseases

Multiple myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. These abnormal plasma cells accumulate in the bone marrow, where they interfere with the production of normal blood cells. The disease typically affects multiple areas of the body, particularly the bones, leading to the formation of tumors within the bone marrow. As the condition progresses, it can cause bone pain, weakness, fatigue, and make bones more susceptible to fractures. Multiple myeloma also often leads to decreased kidney function and a reduction in healthy blood cells.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-516257-44-00Protocol codeRC21_0169 IFM2021-03Estimated enrolment80 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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