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Study on the Effects of Isatuximab with Bortezomib, Lenalidomide, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

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 is focused on studying the treatment of Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is investigating the effectiveness of a combination of medications, including Isatuximab (also known by its code name SAR650984), Bortezomib (Velcade®), Lenalidomide, and Dexamethasone. These medications are being tested together to see if they can improve the condition of patients who have been newly diagnosed with multiple myeloma and are not eligible for a transplant.

The purpose of the study is to determine if adding Isatuximab to the existing treatment of Bortezomib, Lenalidomide, and Dexamethasone can help prolong the time patients live without their disease getting worse, known as progression-free survival. Participants in the study will receive either the combination of all four medications or just the three medications without Isatuximab. Some participants may receive a placebo instead of Isatuximab. The study will last for a period of up to 115 weeks, during which the effects of the treatment will be closely monitored.

Throughout the study, participants will take the medications orally or through injections, depending on the specific drug. The study aims to gather information on how well the treatment works and any side effects that may occur. The results will help determine the potential benefits of this new combination therapy for patients with multiple myeloma who cannot undergo a transplant.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of multiple myeloma and ensuring the patient is not eligible for transplant due to age or other health conditions.

  2. Step 2

    Treatment phase

    The treatment phase involves administering a combination of medications. These include isatuximab, bortezomib, lenalidomide, and dexamethasone.

    Isatuximab is given through an intravenous infusion. Bortezomib is administered via subcutaneous injection. Lenalidomide is taken orally in the form of hard capsules, with varying dosages such as 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Dexamethasone is available as a tablet or an injection solution.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the patient's response to treatment. This includes tracking progression-free survival and other health indicators.

    Patient-reported outcomes are also collected to evaluate quality of life during the trial.

  4. Step 4

    Completion and evaluation

    Upon completion of the treatment phase, a final evaluation is performed to determine the overall response to the therapy.

    The study aims to measure the benefit of adding isatuximab to the treatment regimen in terms of prolonging progression-free survival compared to the standard treatment without it.

Who can join the trial?

5 criteria

  • The patient must have a type of cancer called multiple myeloma. This is a cancer that affects certain cells in the bone marrow.
  • The patient should have been newly diagnosed with multiple myeloma and not be eligible for a transplant. This could be because they are 65 years or older, or if they are younger than 65, they have other health issues that make a transplant not possible.
  • There must be evidence of measurable disease. This means that doctors can measure the cancer in some way to see how it responds to treatment.
  • The patient must provide written informed consent. This means they agree to participate in the study after being fully informed about what it involves.
  • Both male and female patients can participate.

Who cannot join the trial?

4 criteria

  • Patients who have any other type of **cancer** besides the one being studied.
  • Patients who are eligible for a **transplant**. A transplant is a medical procedure where an organ or tissue is moved from one body to another or from one part of the body to another.
  • Patients who are not within the specified **age range** for the study. The age range is the specific ages that are allowed to participate in the study.
  • Patients who are part of a **vulnerable population**. This means groups of people who might need special protection or care, such as children, pregnant women, or people with certain disabilities.
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Investigated drugs

  • Isatuximab

    is a medication being studied for its potential to help treat multiple myeloma, a type of blood cancer. It is used in combination with other medications to see if it can improve the time patients live without their disease getting worse.

  • Bortezomib

    is a medication used to treat multiple myeloma. It works by interfering with the growth of cancer cells, which are eventually destroyed. It is part of the standard treatment regimen for this type of cancer.

  • Lenalidomide

    is another medication used in the treatment of multiple myeloma. It helps the immune system attack cancer cells and also prevents the growth of new blood vessels that tumors need to grow.

  • Dexamethasone

    is a type of steroid that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma, it helps enhance the effects of other cancer treatments.

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, a type of cancer. It is used in combination with other medications like bortezomib, lenalidomide, and dexamethasone. 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 cancer therapy.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The abnormal plasma cells produce a protein known as monoclonal protein or M protein, which can be detected in the blood or urine. Over time, the accumulation of these proteins can lead to organ damage, particularly affecting the kidneys. The progression of multiple myeloma is typically characterized by periods of stability followed by relapses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514417-34-00Protocol codeEFC12522Estimated enrolment517 patientsSponsorSanofi-Aventis Recherche & Developpement

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