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Study on Adding Isatuximab to Lenalidomide, Bortezomib, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will explore the effectiveness of adding Isatuximab to a treatment regimen that includes Lenalidomide, Bortezomib, and Dexamethasone. Isatuximab is given as a solution for infusion, while Lenalidomide is taken orally in capsule form, and Bortezomib is administered as an injection. Dexamethasone is provided in tablet form.

The purpose of the study is to assess whether the addition of Isatuximab improves treatment outcomes for patients with newly diagnosed Multiple Myeloma. Participants will receive a combination of these medications over a period of time, with some receiving a placebo instead of Isatuximab. The study will monitor the patients' response to the treatment, focusing on how well the cancer is controlled and how long patients remain free from disease progression.

Throughout the study, patients will undergo regular assessments to track their health and the effectiveness of the treatment. These assessments will help determine the best approach to managing Multiple Myeloma and improving patient outcomes. The trial aims to provide valuable insights into the potential benefits of combining these medications for treating this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each patient has an equal chance of receiving any of the treatment options being tested.

  2. Step 2

    Induction therapy

    The patient will begin the induction therapy phase, which involves a combination of medications aimed at reducing the number of cancer cells. This phase includes the administration of lenalidomide, isatuximab, bortezomib, and dexamethasone.

    Lenalidomide is taken orally in capsule form. The dosage may vary, with options including 5 mg, 25 mg, 15 mg, or 10 mg, depending on the specific treatment plan.

    Isatuximab is administered through an infusion, which is a process of delivering the medication directly into the bloodstream over a set period.

    Bortezomib is given as a subcutaneous injection, meaning it is injected under the skin.

    Dexamethasone is taken orally in tablet form.

  3. Step 3

    Assessment of minimal residual disease (MRD)

    After the induction therapy, the patient's response to the treatment will be assessed. This involves checking for minimal residual disease (MRD), which refers to the small number of cancer cells that may remain after treatment. The goal is to achieve MRD negativity, indicating that no detectable cancer cells are present.

  4. Step 4

    Maintenance therapy

    If the patient achieves MRD negativity, they will proceed to the maintenance therapy phase. This phase aims to maintain the positive effects of the induction therapy and prevent the cancer from returning.

    During maintenance therapy, the patient will continue to take lenalidomide orally. The specific dosage and duration will be determined based on the patient's response to the induction therapy.

  5. Step 5

    Progression-free survival (PFS) monitoring

    Throughout the trial, the patient's progression-free survival (PFS) will be monitored. PFS refers to the length of time during and after treatment that the patient lives without the cancer worsening.

    Regular assessments will be conducted to ensure the patient's health and to determine the effectiveness of the treatment.

  6. Step 6

    Completion of the trial

    The trial is expected to conclude by March 31, 2027. At the end of the trial, the patient's overall response to the treatment will be evaluated, and any necessary follow-up care will be arranged.

Who can join the trial?

13 criteria

  • The patient must be able to understand the nature and consequences of the clinical trial.
  • The patient must provide written informed consent before joining the trial.
  • The patient must have a confirmed diagnosis of untreated multiple myeloma that requires treatment throughout the body.
  • The patient must be eligible for high-dose therapy and a procedure called autologous stem cell transplantation, which involves using the patient's own stem cells for treatment.
  • The patient must have a measurable disease, which means there must be a quantifiable amount of a specific protein in the body. This can be measured by one of the following:
    • Serum M-protein of at least 10 grams per liter (or 5 grams per liter for a type called IgA).
    • Urine light-chain (M-protein) of at least 200 milligrams in a 24-hour period.
    • Serum FLC assay with an involved sFLC level of at least 10 milligrams per deciliter and an abnormal sFLC ratio.
    • The patient must be between 18 and 70 years old.
    • The patient must have a WHO performance status of 0 to 2, which is a scale that measures the patient's ability to perform daily activities.
    • Females of childbearing potential must have a negative pregnancy test at the start of the trial.
    • All patients must agree to follow the pregnancy prevention plan for a drug called lenalidomide, which includes using effective birth control during the entire treatment.
    • All patients must agree not to donate blood while taking lenalidomide and for 28 days after stopping the medication.
    • All patients must agree not to share the study drug lenalidomide with anyone else and must return any unused medication to the study team or pharmacist.

Who cannot join the trial?

10 criteria

  • Patients who have a different condition than Multiple Myeloma cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who belong to a vulnerable population cannot participate.
  • Patients who do not meet the specific health requirements for the study cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had certain treatments recently that might affect the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of certain diseases or conditions that might affect the study cannot participate.
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Investigated drugs

  • Isatuximab

    is a medication used in this trial to see if it can improve treatment outcomes for patients with newly diagnosed multiple myeloma. It is being tested in combination with other medications to determine if it helps in achieving minimal residual disease negativity, which means reducing the number of cancer cells to very low levels.

  • Lenalidomide

    is a medication that helps to slow or stop the growth of cancer cells. In this trial, it is used both during the initial treatment phase and as a maintenance therapy to help keep the cancer from coming back after the initial treatment.

  • Bortezomib

    is a medication that works by interfering with the growth of cancer cells, leading to their death. It is part of the initial treatment regimen in this trial to help reduce the number of cancer cells in patients with multiple myeloma.

  • Dexamethasone

    is a type of steroid that helps reduce inflammation and can also help kill cancer cells. It is used in combination with other medications in this trial to enhance the overall effectiveness of the treatment for multiple myeloma.

What is already known about the treatment

  • Isatuximab

    Isatuximab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma. It is an investigational drug that is not yet fully approved for widespread use but shows promise in medical literature. The main therapeutic indication for isatuximab is multiple myeloma, a type of blood cancer. At the molecular level, isatuximab works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with cancer cell growth.

  • Lenalidomide

    Lenalidomide is taken orally and is an established medication used in the treatment of multiple myeloma. It is widely recognized in medical literature and is approved for use in various treatment regimens. The primary therapeutic indication for lenalidomide is multiple myeloma, where it helps to slow the growth of cancer cells. Its mechanism of action involves modulating the immune system and inhibiting the growth of blood vessels that supply nutrients to cancer cells. Lenalidomide is classified as an immunomodulatory agent.

  • Bortezomib

    Bortezomib is administered via injection and is a well-known medication used in the treatment of multiple myeloma. It is well-documented in medical literature and is approved for use in combination with other drugs. The main therapeutic indication for bortezomib is multiple myeloma, where it works by inhibiting the proteasome, a complex that breaks down proteins in cells, leading to cancer cell death. Bortezomib is classified as a proteasome inhibitor.

  • Dexamethasone

    Dexamethasone is taken orally or by injection and is a commonly used medication in the treatment of multiple myeloma. It is widely accepted in medical literature and is often used in combination with other drugs. The primary therapeutic indication for dexamethasone is multiple myeloma, where it acts as an anti-inflammatory and immunosuppressant, helping to reduce inflammation and modulate the immune response. Dexamethasone is classified as a corticosteroid.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and other related symptoms. Over time, the disease can cause significant complications, including kidney dysfunction and bone lesions. The progression of Multiple Myeloma varies among individuals, with some experiencing a slow progression while others may have a more aggressive form of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513464-26-00Protocol codeGMMG-HD7Estimated enrolment662 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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