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Study of Isatuximab with drug combination for newly diagnosed multiple myeloma patients with severe kidney problems

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 newly diagnosed Multiple Myeloma, a type of blood cancer affecting plasma cells, who also have severe renal impairment (kidney problems). The research evaluates a combination treatment using several medications: Isatuximab, Bortezomib, Cyclophosphamide, and Dexamethasone during the initial treatment phase, followed by maintenance therapy with Isatuximab and Lenalidomide.

The main purpose of this study is to determine how well the combination of these medications improves kidney function in patients who have both multiple myeloma and severe kidney problems. The treatment consists of two phases: first, patients receive a combination of four medications through different methods - some given by injection into a vein, some taken by mouth, and one given under the skin. After this initial phase, patients continue with maintenance treatment using two medications.

The medications work in different ways to fight the cancer cells: Isatuximab is an antibody that targets specific proteins on cancer cells, Bortezomib helps block cancer cell growth, Cyclophosphamide is a chemotherapy drug that kills cancer cells, Dexamethasone is a steroid that reduces inflammation, and Lenalidomide helps the immune system fight cancer cells. The study will last for up to 36 months for each patient.

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 medications known as VCd regimen plus isatuximab

    The medications include:

    - Isatuximab through intravenous infusion

    - Bortezomib through injection under the skin

    - Cyclophosphamide through intravenous infusion

    - Dexamethasone taken by mouth and sometimes given intravenously

  2. Step 2

    Maintenance phase

    After the initial treatment phase, you will continue with maintenance therapy

    The maintenance medications include:

    - Isatuximab through intravenous infusion

    - Lenalidomide taken by mouth

  3. Step 3

    Monitoring and evaluation

    Regular blood tests will check your kidney function

    Your response to treatment will be monitored through various tests

    The study team will track any side effects for 30 days after your last treatment

    Follow-up visits will continue for up to 36 months from the start of the study

  4. Step 4

    Study completion

    The study will end if:

    - Your disease progresses

    - You need to start a different treatment

    - You complete the planned treatment schedule

    - The maximum follow-up period of 36 months is reached

Who can join the trial?

8 criteria

  • Must be willing to sign an informed consent form and follow study requirements
  • Must be 18 years or older
  • Must have confirmed multiple myeloma diagnosis according to international criteria
  • Must have severe kidney problems with reduced kidney function (filtration rate below 30 ml/min) or need dialysis
  • Must have measurable disease shown by at least one of these: - Certain proteins in blood at specific levels - Certain proteins in urine at specific levels - Abnormal levels of specific light chain proteins in blood
  • Must have adequate bone marrow and liver function shown by: - Sufficient white blood cell count - Hemoglobin level of at least 7.5 g/dL - Adequate platelet count - Liver function tests within acceptable ranges - Normal calcium levels in blood
  • Must have satisfactory physical functioning ability (ECOG score of 2 or less, meaning able to do light work)
  • Any side effects from previous treatments must be resolved or improved to mild level

Who cannot join the trial?

14 criteria

  • Prior treatment for multiple myeloma (except emergency use of local radiotherapy or a short course of steroids)
  • Other types of cancer within the past 3 years (except successfully treated non-melanoma skin cancer or cervical cancer)
  • Significant heart conditions, including:
    • Heart failure (New York Heart Association Class III or IV)
    • Chest pain (angina) that is not well-controlled
    • Heart attack within the past 6 months
    • Active infections requiring treatment
    • Known infection with HIV (human immunodeficiency virus), active hepatitis B, or active hepatitis C
    • Major surgery within 4 weeks before starting the study treatment
    • Pregnancy or breastfeeding
    • Known allergic reactions to any of the study medications
    • Severe liver problems
    • Mental health conditions that could interfere with study participation
    • Any other medical condition that the study doctor believes would make participation unsafe
    • Unable to understand or provide informed consent
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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.

  • Bortezomib

    is an anti-cancer medication that works by blocking certain proteins in cancer cells, causing them to die. It is commonly used in the treatment of multiple myeloma.

  • Cyclophosphamide

    is a chemotherapy medication that helps fight cancer by interfering with cancer cell growth and division. It is used to treat various types of cancer, including multiple myeloma.

  • Dexamethasone

    is a steroid medication that helps reduce inflammation and suppress the immune system. In cancer treatment, it is often used to help manage symptoms and enhance the effectiveness of other cancer medications.

  • Lenalidomide

    is a medication that helps modify the body's immune system to fight cancer cells. It is used as a maintenance therapy in multiple myeloma to help prevent the cancer from returning after initial treatment.

What is already known about the treatment

  • Isatuximab

    A monoclonal antibody medication administered through intravenous infusion, primarily used in the treatment of multiple myeloma, particularly in patients with renal impairment. It works by targeting a specific protein called CD38 on the surface of myeloma cells, helping the immune system to identify and destroy these cancer cells. This medication belongs to the class of targeted immunotherapy drugs and is often used in combination with other anti-myeloma medications for enhanced effectiveness.

  • Bortezomib

    A proteasome inhibitor administered either intravenously or subcutaneously, used in the treatment of multiple myeloma. It works by blocking the proteasome, a cellular complex that breaks down proteins, leading to the death of cancer cells. This medication belongs to the class of targeted cancer therapies and is often combined with other medications to improve treatment outcomes.

  • Cyclophosphamide

    A chemotherapy medication given orally or intravenously, used to treat various types of cancer including multiple myeloma. It works by damaging the DNA of rapidly dividing cells, particularly cancer cells, preventing them from multiplying. This medication belongs to the alkylating agents class of chemotherapy drugs and is commonly used in combination therapy protocols.

  • Dexamethasone

    A corticosteroid medication available in oral and injectable forms, used in multiple myeloma treatment to reduce inflammation and suppress immune system activity. It works by decreasing the body's immune response and can help reduce symptoms associated with cancer and its treatment. This medication belongs to the glucocorticoid class and is frequently used as part of combination therapy in cancer treatment.

  • Lenalidomide

    An oral immunomodulatory drug used in the maintenance treatment of multiple myeloma. It works by enhancing the immune system's ability to fight cancer cells while also preventing the growth of new blood vessels that support tumor growth. This medication belongs to the class of immunomodulatory drugs and is particularly effective in maintenance therapy following initial treatment.

Investigated diseases

  • Multiple Myeloma

    A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. The disease occurs when abnormal plasma cells multiply rapidly in the bone marrow, crowding out healthy blood cells. These cancerous cells produce abnormal proteins that can cause various complications throughout the body. Multiple myeloma can affect multiple areas of the body where bone marrow is active, including the spine, skull, pelvis, and ribs. The disease often leads to bone problems, kidney issues, and decreased blood cell production.

  • Severe Renal Impairment

    A condition where the kidneys lose their ability to effectively filter waste products from the blood. The condition develops when kidney function becomes severely reduced, leading to the buildup of waste products and excess fluid in the body. Renal impairment can affect various bodily functions and disturb the balance of important minerals in the blood. The condition can progress gradually and may be associated with other health conditions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516061-36-00Protocol codeEAE116Estimated enrolment51 patientsSponsorHellenic Society Of Hematology

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