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Study comparing iberdomide, daratumumab and dexamethasone versus daratumumab, bortezomib and dexamethasone in 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 study focuses on patients with Multiple Myeloma, a type of blood cancer that has either not responded to previous treatment or has returned after treatment (known as relapsed or refractory). The study compares two different combination treatments. The first combination includes Iberdomide (also known as CC-220), Daratumumab, and Dexamethasone. The second combination consists of Daratumumab, Bortezomib, and Dexamethasone.

The purpose of this study is to determine which treatment combination works better in treating patients with relapsed or refractory Multiple Myeloma. The medications are given in different ways - some are taken by mouth as tablets or capsules, while others are given through injection under the skin or into a vein. The treatment will continue as long as it remains beneficial for the patient and side effects are manageable.

During the study, doctors will monitor how well the treatments work by checking the amount of cancer cells in the blood and bone marrow. They will also track how long patients live without their disease getting worse and evaluate the overall survival of patients receiving these treatments. Throughout the study, patients will have regular check-ups to monitor their health and any side effects from the treatments.

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

    Your eligibility for the study will be confirmed based on your multiple myeloma diagnosis and previous treatments

    You must have received 1-2 prior treatments for multiple myeloma

    You must have shown improvement with at least one previous treatment

    Your current physical condition will be evaluated using the ECOG performance status scale

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: IberDd - Iberdomide (capsules taken by mouth) + Daratumumab (injection under the skin) + Dexamethasone (tablets taken by mouth)

    Group 2: DVd - Daratumumab (injection under the skin) + Bortezomib (tablets taken by mouth) + Dexamethasone (tablets taken by mouth)

  3. Step 3

    Treatment period

    Regular assessments will monitor your response to treatment

    Blood samples will be taken to measure the level of disease markers

    Bone marrow samples will be collected to check for remaining cancer cells

    Your overall health and any side effects will be monitored throughout the treatment

  4. Step 4

    Follow-up period

    Your health will continue to be monitored after completing treatment

    Regular checks will track if the disease returns or progresses

    Quality of life assessments will be conducted using questionnaires

    The study will continue until September 2028

  5. Step 5

    Safety requirements

    You must follow specific pregnancy prevention measures throughout the study

    Blood donation is not permitted during treatment and for 28 days after

    Regular pregnancy testing is required for individuals who can become pregnant

    Additional safety measures will be explained based on your assigned treatment group

Who can join the trial?

18 criteria

  • Must be at least 18 years old
  • Must have been diagnosed with Multiple Myeloma with measurable disease levels
  • Must have received one to two previous treatments for multiple myeloma
  • Must have shown positive response (improvement) to at least one previous treatment
  • Must have evidence that the disease has progressed during or after the last treatment
  • Must have a performance status score of 0, 1, or 2 (measure of patient's ability to perform daily activities)
  • Must be willing and able to follow the study schedule and requirements
  • Must sign an informed consent form before any study procedures
  • For those who can become pregnant:
    • Must have two negative pregnancy tests
    • Must agree to ongoing pregnancy testing
    • Must use two forms of birth control or practice abstinence
    • For male participants:
      • Must use contraception or practice abstinence during the study and for specified time after
      • Must not donate sperm during the study and for specified time after
      • Must not donate blood during the study and for 28 days after treatment ends
      • Must follow all requirements of the Pregnancy Prevention Program
      • If previously treated with certain medications (CD38-directed therapy):
        • Must have shown positive response to that treatment
        • Must not have had disease progression within 60 days of last dose
        • Must have stopped treatment at least 3 months before joining study

Who cannot join the trial?

16 criteria

  • Prior treatment with iberdomide (an experimental drug for multiple myeloma)
  • Active central nervous system involvement of multiple myeloma
  • Known allergy or sensitivity to any of the study medications
  • Previous stem cell transplant within 12 weeks before starting the study
  • Significant heart conditions including heart failure or recent heart attack (within 6 months)
  • Active or chronic liver disease
  • Other types of cancer requiring treatment (except for successfully treated skin cancer or cervical cancer)
  • Uncontrolled high blood pressure
  • Serious infections requiring treatment
  • Pregnancy or breastfeeding
  • Unable to take blood-thinning medications
  • Major surgery within 2 weeks before starting the study
  • Peripheral neuropathy (nerve damage causing numbness or tingling) grade 2 or higher
  • Participation in other clinical trials within 28 days before this study
  • Mental conditions that could interfere with following study procedures
  • Unable to take oral medications
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Investigated drugs

  • Iberdomide

    (also known as BMS-986382) is a medication being studied for treating relapsed or refractory multiple myeloma. It belongs to a new class of drugs that helps the immune system fight cancer cells.

  • Daratumumab

    is an antibody medication that targets specific proteins on myeloma cells. It works by helping the body's immune system recognize and destroy cancer cells in multiple myeloma.

  • Dexamethasone

    is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often combined with other medications to enhance their effectiveness.

  • Bortezomib

    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, causing the cancer cells to die.

What is already known about the treatment

  • Iberdomide

    An investigational oral medication being studied for the treatment of relapsed or refractory multiple myeloma, working as a novel cereblon E3 ligase modulator. This drug is administered in tablet form and is being evaluated in combination with daratumumab and dexamethasone in clinical trials, showing promise in treating patients who have failed previous therapies. It represents a new generation of immunomodulatory drugs that target specific protein degradation pathways in cancer cells.

  • Daratumumab

    A monoclonal antibody medication administered through intravenous infusion, targeting the CD38 protein found on multiple myeloma cells. This established treatment is approved for use in multiple myeloma and works by helping the immune system identify and destroy cancer cells while also having direct anti-tumor effects. It's commonly used in combination therapy and has shown significant efficacy in treating relapsed or refractory multiple myeloma.

  • Dexamethasone

    A corticosteroid medication typically taken orally or given intravenously, widely used in multiple myeloma treatment regimens for its anti-inflammatory and immunosuppressive properties. It helps reduce cancer-related inflammation and can enhance the effectiveness of other anti-myeloma treatments while managing treatment-related symptoms. This medication is a standard component in many multiple myeloma combination therapies.

  • Bortezomib

    A proteasome inhibitor administered either subcutaneously or intravenously, used in the treatment of multiple myeloma by blocking protein breakdown in cancer cells, leading to their death. This established medication has been a cornerstone in multiple myeloma therapy for many years and is often used in combination with other drugs to achieve better treatment outcomes. It works by disrupting cellular processes that cancer cells rely on for survival.

Investigated diseases

  • Multiple Myeloma

    A blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of defective antibodies that build up in the body. The disease typically affects multiple bones in the body, hence its name. Over time, the condition can damage bones, lead to high blood calcium levels, and cause problems with blood cell production. The disease often progresses through cycles of active disease and remission.

  • Relapsed Multiple Myeloma

    A form of multiple myeloma that has returned after a period of remission or response to previous treatment. The disease shows signs of progression after a period when it was under control.

  • Refractory Multiple Myeloma

    A form of multiple myeloma that does not respond to current therapy, or stops responding during treatment. The disease continues to progress despite ongoing treatment efforts.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510800-35-00Protocol codeCC-220-MM-002Estimated enrolment864 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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