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Study of Isatuximab, 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 a condition called multiple myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study is specifically for patients who have been newly diagnosed with multiple myeloma and are not eligible for a transplant. The treatment being tested includes a combination of medications: isatuximab, bortezomib, lenalidomide, and dexamethasone. Isatuximab, also known by its code name SAR650984, is a humanized monoclonal antibody that targets a protein called CD38 on the surface of cancer cells. Bortezomib is a medication that helps to slow down or stop the growth of cancer cells, while lenalidomide and dexamethasone are used to help the immune system fight cancer and reduce inflammation, respectively.

The purpose of this study is to evaluate how well this combination of medications works in treating multiple myeloma. Participants in the study will receive these medications in different forms: isatuximab will be given as a subcutaneous injection, which means it is injected under the skin using a special device, bortezomib will be administered as an intravenous injection, lenalidomide will be taken as oral capsules, and dexamethasone will be provided as either an oral solution or tablets. The study will monitor participants over a period of time to assess their response to the treatment, including how well the cancer responds and any side effects experienced.

Throughout the study, participants will be regularly assessed to determine the effectiveness of the treatment and to monitor their overall health and quality of life. The study aims to gather information on the very good partial response rate, which is a measure of how much the cancer has shrunk or disappeared after treatment. Additionally, the study will look at other outcomes such as overall survival, progression-free survival, and the duration of response to the treatment. Participants' experiences and satisfaction with the treatment will also be evaluated to ensure the best possible care and outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of isatuximab through subcutaneous injection. This medication is used to target specific cells in the body.

    Alongside isatuximab, bortezomib is administered intravenously. This medication helps to slow or stop the growth of cancer cells.

    The patient will also take lenalidomide orally in the form of hard capsules. This medication is designed to enhance the immune system's ability to fight cancer.

    Additionally, dexamethasone is taken orally. This medication is a type of steroid that helps reduce inflammation and manage side effects.

  2. Step 2

    Ongoing treatment and monitoring

    The treatment regimen continues with regular administration of the medications as prescribed. The frequency and dosage will be determined by the healthcare provider based on individual response and tolerance.

    Regular monitoring of health status is conducted to assess the effectiveness of the treatment and to manage any side effects. This includes blood tests and other necessary evaluations.

  3. Step 3

    Response evaluation

    The primary goal is to evaluate the very good partial response rate (VGPR) in patients. This involves assessing how well the cancer responds to the treatment.

    Secondary evaluations include measuring overall survival, progression-free survival, and other response rates according to international criteria.

  4. Step 4

    Patient experience assessment

    Patient experience and satisfaction with the treatment are assessed through questionnaires. This helps to understand the impact of the treatment on quality of life.

    The safety of the treatment is also monitored, including any reactions to the medications and their administration.

  5. Step 5

    Long-term follow-up

    The study is expected to continue until October 2028, with ongoing assessments to determine the long-term effectiveness and safety of the treatment.

    Patients will be followed up regularly to monitor their health status and any long-term effects of the treatment.

Who can join the trial?

27 criteria

  • Must be able to understand and voluntarily sign an informed consent form.
  • Must have adequate organ function, which means the organs are working well enough. This is checked by:
    • Serum total bilirubin less than 2 times the upper limit of normal.
    • Creatinine clearance of at least 30 ml/min, which is a measure of kidney function.
    • Serum SGOT/AST or SGPT/ALT less than 3 times the upper limit of normal, which are liver enzymes.
    • Must be affiliated with the French social security system or an equivalent system.
    • If a man is sexually active with a pregnant woman or a woman who can become pregnant, he must agree to use a barrier method of birth control, like a condom with spermicidal foam or gel, during the study and for at least 5 months after the last dose of treatment.
    • A female participant must not be pregnant or breastfeeding and must meet one of the following:
      • Not able to become pregnant.
      • If able to become pregnant, must have a negative pregnancy test before starting the study and before each treatment cycle. Must agree to use two reliable methods of contraception or abstain from sex during the study and for at least 5 months after the last dose.
      • Must understand and agree to follow the conditions of the Lenalidomide pregnancy prevention plan.
      • Must be able to attend study visits and follow other study requirements.
      • Must be able to swallow oral treatments.
      • Must have a life expectancy of more than 6 months.
      • Must be at least 65 years old.
      • Must have newly diagnosed multiple myeloma that requires therapy. This includes:
        • Monoclonal plasma cells in the bone marrow of at least 10% or a biopsy-proven plasmacytoma.
        • Evidence of end organ damage due to the disease, such as:
          • High calcium levels in the blood.
          • Kidney problems.
          • Anemia, which is a low level of red blood cells.
          • Bone lesions, which are areas of bone damage.
          • Specific biomarkers of the disease, like a high percentage of certain cells in the bone marrow or abnormal protein levels in the blood.
          • Must have measurable disease, which means the disease can be measured by:
            • Serum monoclonal paraprotein level of at least 5 g/L.
            • Urine M-protein level of at least 200 mg/24 hours.
            • Serum immunoglobulin free light chain level of at least 100 mg/L with an abnormal ratio.
            • Must not be eligible for a transplant, meaning:
              • Newly diagnosed and not a candidate for high-dose chemotherapy with stem cell transplant.
              • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, which is a measure of how well a person can perform daily activities.
              • Must have adequate bone marrow function, which means the bone marrow is working well enough. This is checked by:
                • Absolute neutrophils of at least 1 x 109/L, which are a type of white blood cell.
                • Untransfused platelet count of at least 75 x 109/L, which are cells that help with blood clotting.
                • Hemoglobin of at least 8.5 g/dL, which is a measure of red blood cells.

Who cannot join the trial?

5 criteria

  • Patients who have not been newly diagnosed with **multiple myeloma**. Multiple myeloma is a type of cancer that affects certain blood cells in the bone marrow.
  • 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.
  • Patients who belong to a group that is not included in the study's target population.
  • Patients who are not considered part of the vulnerable population selected for the study.
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Investigated drugs

  • Isatuximab

    is a medication used in this trial to help treat multiple myeloma, a type of blood cancer. It works by targeting and attaching to a specific protein on the surface of cancer cells, which helps the immune system to identify and destroy these cells.

  • Bortezomib

    is a medication that helps treat multiple myeloma by interfering with the growth of cancer cells. It works by blocking a certain protein inside the cells, which leads to the death of cancer cells and slows down the progression of the disease.

  • Lenalidomide

    is a medication used in the treatment of multiple myeloma. It helps the immune system to attack cancer cells and also stops the growth of new blood vessels that tumors need to grow. This dual action helps to control the spread of the disease.

  • Dexamethasone

    is a type of steroid used in this trial to help reduce inflammation and suppress the immune system. In the context of multiple myeloma, it is used to enhance the effectiveness of other cancer treatments and help manage symptoms associated with the disease.

What is already known about the treatment

Isatuximab – Isatuximab is administered as a subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating newly diagnosed multiple myeloma in patients who are not eligible for a transplant. It is an investigational drug that is gaining attention in medical literature for its potential benefits in this specific type of cancer. The main therapeutic indication for isatuximab is multiple myeloma, a cancer of plasma cells. At the molecular level, isatuximab works by targeting a specific protein on the surface of cancer cells, leading to their destruction. 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 blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to bone damage, kidney problems, and a weakened immune system. As the disease progresses, it can cause bone pain, fractures, fatigue, and frequent infections. The accumulation of these abnormal cells can also lead to anemia and high levels of calcium in the blood. Over time, the disease can affect various organs and systems in the body, causing a range of symptoms and complications.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-517099-39-00Protocol codeISASOCUT-IFM2022-05Estimated enrolment74 patientsSponsorCentre Hospitalier Universitaire De Poitiers

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