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Study of isatuximab, belumosudil and dexamethasone combination treatment 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 will test a combination of three medications: isatuximab (given through an intravenous infusion), belumosudil (taken as a film-coated tablet), and dexamethasone (taken as a tablet). Multiple Myeloma is a type of blood cancer that affects plasma cells, which are special white blood cells that help fight infections.

The purpose of this study is to find the right dose of these medications when used together and to see how well they work in treating Multiple Myeloma that has come back or is not responding to other treatments. The study is divided into two parts: first, researchers will determine the best dose of the medications, and then they will test how well this combination works in more patients.

During the study, participants will receive the combination of these medications. The treatment will continue as long as it is helping the patient and any side effects can be managed. Researchers will monitor how the cancer responds to the treatment and track any side effects that may occur. They will also look at how the medications work in the body and assess how the treatment affects patients' quality of life.

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 treatment cycle

    Treatment consists of three medications: isatuximab (given through intravenous infusion), belumosudil (taken as oral tablets), and dexamethasone (taken as oral tablets)

    Treatment is provided to patients with relapsed or refractory multiple myeloma who have received at least 2 prior therapies

  2. Step 2

    Regular monitoring

    Your doctor will monitor the response to treatment through regular blood tests that measure protein levels

    Quality of life assessments will be conducted using standardized questionnaires

    Side effects will be tracked throughout the treatment period

  3. Step 3

    Treatment continuation

    Treatment continues as long as it provides benefit and is well-tolerated

    Regular evaluations will assess how well the cancer is responding to treatment

    Blood samples will be collected to measure medication levels in your body

  4. Step 4

    Follow-up period

    After completing treatment, you will have follow-up visits to monitor your health status

    Your doctor will continue to track your overall survival and disease progression

    The study is planned to continue until September 2028

Who can join the trial?

10 criteria

  • Must be 18 years of age or older
  • Must have an ECOG performance status of 0-1 (meaning able to perform daily activities with minimal or no restrictions)
  • 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
      • Certain levels of light chain proteins in blood when other proteins are not measurable
      • Must be willing to use effective birth control methods during the study (applies to both men and women who can have children)
      • For specific study group (Substudy 05): Must have received at least 2 cycles of:
        • Previous anti-CD38 therapy
        • BCMA targeted therapy (if available in your region)

Who cannot join the trial?

15 criteria

  • Prior treatment with isatuximab (a type of cancer medication) or any other anti-CD38 antibody therapy
  • Active brain metastases (cancer that has spread to the brain) or symptoms suggesting brain involvement
  • History of severe allergic reactions to monoclonal antibodies (a type of targeted therapy)
  • Significant heart conditions including heart failure, irregular heartbeat, or recent heart attack (within 6 months)
  • Active or chronic infections, including:
    • Hepatitis B
    • Hepatitis C
    • HIV
    • Other active cancers requiring treatment (except for certain skin cancers or early-stage cancers that have been successfully treated)
    • Severe kidney problems requiring dialysis
    • Severe liver dysfunction
    • Pregnancy or breastfeeding
    • Unable to use effective contraception during the study and for 5 months after the last dose
    • Participation in other clinical trials within 30 days before starting this study
    • Mental conditions that could interfere with following study procedures
    • Any medical condition that the study doctor believes would make participation unsafe
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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.

  • Belumosudil

    (also known as SAR445761) is a medication that helps regulate the immune system's response. In this trial, it is being tested in combination with other medications to treat multiple myeloma that has returned or stopped responding to previous treatments.

  • Dexamethasone

    is a steroid medication commonly used in cancer treatment. It helps reduce inflammation and can make other cancer treatments more effective. It is often used in combination with other medications to treat multiple myeloma.

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. This medication works by targeting the CD38 protein found on myeloma cells, triggering their destruction and helping the immune system fight cancer cells. It belongs to the class of targeted immunotherapy drugs and is typically used in combination with other anti-cancer medications to enhance treatment effectiveness.

  • Belumosudil

    An oral medication that functions as a ROCK2 (rho-associated protein kinase 2) inhibitor, developed for treating various forms of cancer, including multiple myeloma. This drug works by modulating cellular signaling pathways involved in cancer cell survival and proliferation, potentially enhancing the body's immune response against cancer cells. It represents a newer class of targeted therapy medications and is being studied in combination with other treatments to improve outcomes for patients with resistant forms of multiple myeloma.

  • Dexamethasone

    An oral or injectable corticosteroid medication commonly used in cancer treatment protocols, particularly in multiple myeloma therapy. This drug works by reducing inflammation and suppressing immune system activity, which can help control cancer growth and manage treatment-related symptoms. It belongs to the glucocorticoid class of medications and is frequently combined with other cancer treatments to enhance their effectiveness and manage side effects.

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 a single type of antibody, known as M protein. The disease can cause bone pain, frequent infections, fatigue, kidney problems, and weakening of the bones. Multiple myeloma typically progresses through different stages, with periods of active disease alternating with periods of remission.

  • Cancer

    A disease characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells divide rapidly and can invade nearby tissues, potentially spreading to other parts of the body through the blood and lymph systems. Cancer cells develop due to damage or changes to DNA, which can be caused by various environmental or genetic factors. The disease can affect any part of the body and typically forms solid tumors, except in blood cancers. Cancer cells interfere with normal cell functions and can disrupt organ systems.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514992-16-00Protocol codeACT16482-05Estimated enrolment54 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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