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Study on Isatuximab, Lenalidomide, and Dexamethasone for Elderly 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 treatments for Multiple Myeloma, a type of blood cancer that affects elderly patients who are newly diagnosed and not eligible for a transplant. The study will explore the effectiveness of a combination of medications, including Isatuximab, Lenalidomide, Dexamethasone, and possibly Bortezomib. Isatuximab is a humanized monoclonal antibody, which means it is a type of protein designed to target specific cells in the body. Lenalidomide and Dexamethasone are medications that help control the growth of cancer cells, while Bortezomib is used to prevent cancer cells from multiplying.

The purpose of this study is to evaluate the effectiveness of these treatments in reducing the presence of cancer cells in the bone marrow over a period of 18 months. Participants will receive the medications either through oral solutions, tablets, or injections, depending on the specific drug. The study will monitor the participants' health and response to the treatment over time, with regular check-ups and assessments to ensure safety and effectiveness.

Throughout the study, researchers will collect data on various health parameters, including the rate of response to the treatment and any side effects experienced. The goal is to determine the best combination of these medications for treating Multiple Myeloma in elderly patients who are not candidates for high-dose chemotherapy and stem cell transplant. The study is expected to continue until 2026, providing valuable insights into the management of this condition.

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

    Initial visit and consent

    Upon joining the study, the first step involves an initial visit where the patient will be asked to sign an informed consent form. This form confirms that the patient understands the study and agrees to participate voluntarily.

  2. Step 2

    Screening and baseline assessments

    The patient will undergo various assessments to ensure eligibility for the trial. These assessments include blood tests to check organ function and bone marrow tests to confirm the diagnosis of multiple myeloma.

    The patient must meet specific health criteria, such as adequate organ function and bone marrow function, to proceed with the trial.

  3. Step 3

    Treatment initiation

    The treatment phase begins with the administration of medications. The patient will receive isatuximab through an intravenous infusion, which means the medication is given directly into a vein.

    The patient will also take lenalidomide in the form of oral capsules and dexamethasone orally. The specific dosages and frequency will be provided by the healthcare team.

  4. Step 4

    Treatment with bortezomib

    In some cases, the patient may also receive bortezomib, which is administered as a subcutaneous injection, meaning it is injected under the skin.

    The decision to include bortezomib in the treatment plan will be based on the specific requirements of the study.

  5. Step 5

    Ongoing monitoring and assessments

    Throughout the trial, the patient will have regular visits to monitor health and response to treatment. This includes blood tests, bone marrow tests, and assessments of any side effects.

    The healthcare team will evaluate the patient's response to the treatment and make any necessary adjustments.

  6. Step 6

    End of treatment and follow-up

    After completing the treatment phase, the patient will have follow-up visits to assess long-term health and any lasting effects of the treatment.

    The study aims to evaluate the effectiveness of the treatment in achieving minimal residual disease, which means reducing cancer cells to very low levels.

Who can join the trial?

14 criteria

  • Must be able to understand and voluntarily sign an informed consent form.
  • Must be able to follow the study visit schedule and other study requirements.
  • Must have a life expectancy of more than 6 months.
  • Must be between the ages of 65 and 79 years old.
  • Must have been newly diagnosed with multiple myeloma that requires treatment. This includes having a certain percentage of specific cells in the bone marrow or a confirmed tumor.
  • Must have a measurable disease, which means certain levels of specific proteins in the blood or urine.
  • Must not be eligible for a transplant and must not be considered frail. This means the patient is newly diagnosed and not a candidate for high-dose chemotherapy with stem cell transplant (SCT) and is not frail.
  • Must have a performance status of ECOG ≤ 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Must have adequate bone marrow function, which means certain levels of blood cells without recent transfusions or growth factor support.
  • Must have adequate organ function, which includes specific levels of bilirubin, creatinine clearance, and liver enzymes.
  • Must be affiliated with an appropriate social security 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, 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 certain conditions regarding pregnancy prevention, including using effective birth control methods.
  • All patients must understand and agree to comply with the conditions of the lenalidomide pregnancy prevention plan.

Who cannot join the trial?

5 criteria

  • Patients who have not been newly diagnosed with **Multiple Myeloma** cannot participate. **Multiple Myeloma** is a type of cancer that affects plasma cells in the bone marrow.
  • Patients who are considered **frail** are not eligible. **Frail** means having a reduced physical strength and health, often due to aging.
  • Patients who are eligible for a **transplant** cannot participate. A **transplant** refers to receiving a healthy organ or tissue from another person.
  • Patients who are not elderly are excluded. **Elderly** generally refers to older adults, often over the age of 65.
  • Patients who are part of a **vulnerable population** are not eligible. **Vulnerable population** includes groups who may have limited ability to protect their own interests, such as children or those with certain disabilities.
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Investigated drugs

  • Isatuximab

    is a type of medication known as a monoclonal antibody. It works by targeting and attaching to a specific protein found on the surface of multiple myeloma cells. This helps the body's immune system to recognize and destroy these cancer cells. In this trial, Isatuximab is being used to help treat patients with multiple myeloma, a type of blood cancer.

  • Lenalidomide

    is a medication that helps the immune system fight cancer. It works by stopping the growth of cancer cells and by helping the immune system to attack them. Lenalidomide is used in this trial to treat multiple myeloma by slowing down or stopping the progression of the disease.

  • Dexamethasone

    is a type of steroid medication. It is used to reduce inflammation and to help control the immune system. In the context of this trial, Dexamethasone is used to help manage multiple myeloma by reducing inflammation and helping other medications work more effectively against cancer cells.

  • Bortezomib

    is a medication that interferes with the growth of cancer cells. It works by blocking a certain protein that cancer cells need to grow and multiply. In this trial, Bortezomib is used to help treat multiple myeloma by slowing down or stopping the growth of cancer cells.

What is already known about the treatment

  • Isatuximab

    Isatuximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer, particularly in elderly patients who are not eligible for a transplant. The medication works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. Isatuximab is classified as a monoclonal antibody, which is a type of drug designed to mimic the immune system's ability to fight off harmful pathogens.

  • Lenalidomide

    Lenalidomide is taken orally in the form of a capsule. It is widely used in the treatment of multiple myeloma and is well-documented in medical literature for its effectiveness in this area. The drug works by affecting the immune system and directly attacking cancer cells, slowing their growth and spread. Lenalidomide is classified as an immunomodulatory agent, which means it modifies the immune response to help fight cancer.

  • Dexamethasone

    Dexamethasone is usually taken orally in tablet form, but it can also be administered intravenously. It is a well-established medication used in combination with other drugs to treat multiple myeloma. Dexamethasone works by reducing inflammation and suppressing the immune system, which can help control the symptoms of cancer. It is classified as a corticosteroid, a type of steroid hormone that reduces inflammation and affects the immune system.

  • Bortezomib

    Bortezomib is administered through an injection, either under the skin or directly into a vein. It is a well-known treatment for multiple myeloma and is often used in combination with other medications. Bortezomib works by inhibiting the proteasome, a complex that breaks down proteins in cells, leading to the accumulation of proteins that can cause cancer cell death. It is classified as a proteasome inhibitor, a type of drug that blocks the action of proteasomes in cells.

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. It begins when a single plasma cell becomes abnormal and multiplies rapidly, leading to an accumulation of abnormal cells in the bone marrow. These abnormal cells produce a large amount of a single type of antibody, which can cause damage to bones and interfere with the production of normal blood cells. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The progression of Multiple Myeloma is typically characterized by periods of stability followed by relapses, where the disease becomes more active. Over time, the disease can become more aggressive and resistant to treatment.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-517215-67-00Protocol codeIFM2020-05-BENEFITEstimated enrolment270 patientsSponsorCentre Hospitalier Universitaire De Poitiers

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