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Study of isatuximab, evorpacept and dexamethasone combination therapy 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 focuses on treating Multiple Myeloma that has returned or stopped responding to previous treatments. The study tests a combination of three medications: isatuximab (given through an intravenous infusion), evorpacept (given as an injection), and dexamethasone (taken as tablets). Multiple Myeloma is a type of blood cancer that affects plasma cells, which are cells in the bone marrow that help fight infections.

The main purpose of this study is to find the best dose of these medications when used together and to see how well they work in treating Multiple Myeloma that has come back after at least two previous treatments. The study is divided into two parts: the first part focuses on finding the right dose combination, while the second part looks at how effective this treatment is at controlling the cancer.

During the study, participants will receive the combination of medications and will be monitored regularly to check how their cancer responds to the treatment. The medications work in different ways to fight cancer cells: isatuximab targets specific proteins on cancer cells, evorpacept helps the immune system fight cancer cells, and dexamethasone helps reduce inflammation and supports the other medications' effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial eligibility verification

    Your eligibility will be verified based on the following main criteria:

    - Age must be 18 years or older

    - You must have received at least 2 prior treatments for multiple myeloma

    - Your physical condition score (ECOG) must be 0-1, meaning you are able to carry out light daily activities

    - Your disease must be measurable through specific blood or urine tests

  2. Step 2

    Treatment administration

    You will receive a combination of three medications:

    - Dexamethasone tablets taken by mouth

    - Isatuximab given through an intravenous infusion (into a vein)

    - Evorpacept given through an intravenous infusion

    The exact doses and schedule will be determined during the study

  3. Step 3

    Monitoring and assessments

    Regular assessments will include:

    - Blood tests to measure disease markers

    - Quality of life questionnaires about your health and symptoms

    - Regular checks for any side effects

    - Monitoring of your response to treatment

  4. Step 4

    Follow-up period

    The study will continue until September 2028

    Your progress will be monitored to assess:

    - How well the treatment is working

    - How long the response to treatment lasts

    - Your overall survival and health status

Who can join the trial?

10 criteria

  • Must be 18 years of age or older
  • Must have a performance status score of 0-1 on the ECOG scale (means you are able to carry out normal activities with minimal symptoms)
  • Must have multiple myeloma that has returned or not responded to at least 2 previous treatments, including:
    • Proteasome inhibitors (PIs)
    • Immunomodulatory drugs (IMiDs)
    • Must have measurable disease shown by at least one of these:
      • Blood protein level (M protein) of 0.5 g/dL or higher
      • Urine protein level (M protein) of 200 mg or more in 24 hours
      • Specific blood protein levels (serum free light chains) of 10 mg/dL or higher with abnormal ratios
      • Must be willing to use birth control methods if able to have children
      • For specific study group (Substudy 06): Must either:
        • Never have received anti-CD38 therapy, or
        • Had previous anti-CD38 therapy (at least 2 treatment cycles) with last dose 12 or more months ago

Who cannot join the trial?

15 criteria

  • Prior treatment with isatuximab (a type of cancer medication) or any other anti-CD38 antibody therapy
  • Active or history of central nervous system involvement (cancer spread to brain or spinal cord)
  • Known hypersensitivity (severe allergic reaction) to study medications or their components
  • Significant heart conditions including:
    • Heart failure (when heart cannot pump blood effectively)
    • Unstable heart rhythm problems
    • Heart attack within past 6 months
    • Active or chronic hepatitis B or C infection (liver infections)
    • Known positive test for HIV infection
    • Other active cancers requiring treatment (except for certain skin cancers or cervical cancer in situ)
    • Major surgery within 4 weeks before starting the study
    • Participation in other clinical trials within 4 weeks before starting this study
    • Plasma cell leukemia (an aggressive type of blood cancer)
    • Pregnancy or breastfeeding
    • Unable to take blood-thinning medications
    • Serious active infections requiring treatment
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Investigated drugs

  • Isatuximab

    is a medication used to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on cancer cells, helping the immune system to identify and destroy these cells.

  • Evorpacept

    is an experimental medication being studied for the treatment of multiple myeloma. It is designed to block a signal that cancer cells use to avoid being detected by the immune system.

  • Dexamethasone

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

What is already known about the treatment

  • Isatuximab

    An intravenously administered monoclonal antibody used in the treatment of multiple myeloma, particularly in relapsed or refractory cases. It works by targeting CD38, a protein highly expressed on myeloma cells, leading to their destruction through multiple immune-mediated mechanisms. This medication belongs to the class of targeted immunotherapy drugs and is typically used in combination with other anti-cancer medications to enhance treatment effectiveness.

  • Evorpacept

    A novel investigational immunotherapy drug administered intravenously that blocks CD47, a "don't eat me" signal that cancer cells use to evade immune system detection. It works by enabling macrophages and other immune cells to better recognize and eliminate cancer cells, particularly in blood cancers like multiple myeloma. This medication is currently being studied in clinical trials as part of combination therapy approaches.

  • Dexamethasone

    An orally or intravenously administered corticosteroid commonly used in combination with other medications for treating multiple myeloma and other cancers. It works by reducing inflammation and suppressing the immune system, helping to control cancer growth while managing treatment-related symptoms. This well-established medication belongs to the glucocorticoid class and is frequently included in multiple myeloma treatment protocols.

Investigated diseases

  • Multiple Myeloma

    A type of 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 called M proteins. The disease can weaken bones, reduce kidney function, and decrease the production of normal blood cells. Multiple myeloma often progresses slowly and can affect multiple areas of the body, particularly the bones of the spine, skull, pelvis, rib cage, and hips.

  • Cancer

    A disease characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells divide rapidly and can form masses called tumors, which can interfere with normal body functions. Cancer cells can break away from their original location and spread to other parts of the body through blood vessels and lymph nodes. The disease develops when genetic changes interfere with normal cell growth and division control mechanisms. Different types of cancer can affect various organs and tissues throughout the body.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514993-38-00Protocol codeACT16482-06Estimated enrolment48 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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