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Study of isatuximab, belantamab mafodotin and dexamethasone combination 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 study focuses on patients with relapsed or refractory multiple myeloma, a type of blood cancer that returns after treatment or does not respond to previous treatments. The study will test a combination of three medications: isatuximab, belantamab mafodotin, and dexamethasone. Isatuximab and belantamab mafodotin are specialized drugs that target specific proteins on cancer cells, while dexamethasone is a steroid medication that helps fight cancer cells.

The purpose of this research is to find the most effective and safe dose of these medications when used together in treating multiple myeloma that has returned or not responded to at least two previous treatments. The study is divided into two parts - the first part will determine the right dose of the medications, and the second part will test how well the combination works at the chosen dose.

During the study, participants will receive the medications through different routes - isatuximab and belantamab mafodotin will be given through an intravenous infusion (directly into a vein), while dexamethasone will be taken as tablets by mouth. The study will monitor how participants respond to the treatment and track any side effects that may occur.

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 phase

    You will receive a combination of three medications: isatuximab (given through intravenous infusion), belantamab mafodotin (given through intravenous infusion), and dexamethasone (taken as oral tablets)

    This treatment is designed for multiple myeloma that has returned or not responded to at least 2 previous treatments

  2. Step 2

    Regular assessments

    Your response to treatment will be monitored through regular blood tests to measure protein levels

    Your overall health status will be evaluated using various questionnaires about your quality of life and any side effects

    Your vision will be regularly checked, as this is part of the safety monitoring

  3. Step 3

    Treatment monitoring

    The medical team will track how quickly your disease responds to treatment

    The duration of your response to treatment will be monitored

    Regular blood samples will be taken to measure medication levels in your body

  4. Step 4

    Long-term follow-up

    Your progress will be monitored until September 2028

    The medical team will track your overall survival and how long you remain free from disease progression

    You will continue to complete quality of life questionnaires during this period

Who can join the trial?

10 criteria

  • You must be 18 years or older to participate
  • You must have a good level of physical fitness, scoring 0-1 on the ECOG scale (this means you are fully active or slightly restricted in strenuous activities but able to carry out light work)
  • You must have multiple myeloma that has returned or not responded to at least 2 previous treatments, including specific types of therapy called proteasome inhibitors and immunomodulatory drugs
  • Your disease must be measurable in one of these ways:
    • A specific protein level (M protein) in your blood of 0.5 g/dL or higher
    • A specific protein level (M protein) in your urine of 200 mg or more in 24 hours
    • Certain levels of light chain proteins in your blood if M protein cannot be measured
    • If you can have children, you must agree to use contraception during the study
    • If you have received previous anti-CD38 therapy (a specific type of cancer treatment), you must have:
      • Either never received this treatment before, or
      • Had your last treatment at least 6 months ago
      • Not had your disease worsen within 60 days of your last anti-CD38 treatment

Who cannot join the trial?

14 criteria

  • Prior treatment with isatuximab (a type of cancer medication) or any other anti-CD38 antibody therapy
  • Active central nervous system involvement from multiple myeloma (cancer spread to brain or spinal cord)
  • Significant heart conditions, including heart failure, irregular heartbeat, or recent heart attack within the past 6 months
  • Known active hepatitis B or C infection (liver infections)
  • HIV infection or AIDS
  • Other types of cancer within the past 3 years, except for successfully treated skin cancer or cervical cancer
  • Major surgery within 4 weeks before starting the study
  • Participation in other clinical trials within 4 weeks before this study
  • Severe kidney dysfunction requiring dialysis
  • Known allergic reactions to study medications or their components
  • Pregnant or breastfeeding women
  • Unwillingness to use effective contraception during the study period
  • Plasma cell leukemia (a severe form of blood cancer)
  • Any medical condition that could interfere with study participation or affect results
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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.

  • Belantamab mafodotin

    is also a medication used to treat multiple myeloma. It works by delivering a cancer-killing substance directly to cancer cells that express a specific protein called BCMA.

  • 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 certain side effects.

What is already known about the treatment

  • Isatuximab

    A monoclonal antibody administered through intravenous infusion, used in the treatment of multiple myeloma, particularly in patients with relapsed or refractory disease. This medication works by targeting the CD38 protein found on myeloma cells, helping the immune system to identify and destroy cancer cells more effectively. It belongs to the class of targeted immunotherapy drugs and is often used in combination with other anti-myeloma medications to enhance treatment effectiveness.

  • Belantamab mafodotin

    An antibody-drug conjugate given through intravenous infusion, specifically developed for treating relapsed or refractory multiple myeloma. It works by targeting the B-cell maturation antigen (BCMA) on myeloma cells and delivering a toxic payload directly to cancer cells, while minimizing damage to healthy tissues. This medication represents an innovative approach in targeted cancer therapy and is typically used when patients have exhausted other treatment options.

  • Dexamethasone

    A synthetic corticosteroid medication available in oral or injectable forms, commonly used in combination with other cancer treatments for multiple myeloma. It works by reducing inflammation and suppressing the immune system, which can help control cancer growth and manage treatment-related symptoms. This medication belongs to the glucocorticoid class and is a standard component of many multiple myeloma treatment regimens.

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 disease, cancerous plasma cells accumulate in the bone marrow, crowding out healthy blood cells and producing abnormal proteins. These abnormal cells can cause bone damage, kidney problems, and a decrease in normal blood cell production. Multiple myeloma often develops slowly and may progress through different stages, from early disease to relapsed or refractory forms. The condition typically affects multiple areas of the body where bone marrow is active.

  • Cancer

    A disease characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells divide and grow uncontrollably, forming masses or tumors that can invade nearby tissues. Cancer cells can break away from their original location and spread to other parts of the body through blood vessels or lymph nodes. The disease can develop in almost any organ or tissue and may affect normal body functions as it progresses. Cancer typically develops gradually, often starting from a single abnormal cell that multiplies over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514989-40-00Protocol codeACT16482-03Estimated enrolment3 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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