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Study on Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone for Patients with Newly Diagnosed Low-Risk Multiple Myeloma

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 disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is evaluating a treatment that includes a combination of medications: Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone. These medications are used to target and treat the cancer cells in different ways. The purpose of the study is to compare the effectiveness of two different treatment approaches for patients who have been newly diagnosed with low-risk multiple myeloma.

Participants in the study will receive either six cycles of treatment with the combination of isatuximab, lenalidomide, bortezomib, and dexamethasone, followed by maintenance therapy with lenalidomide and isatuximab, or three cycles of the same combination followed by one cycle of high-dose therapy and maintenance therapy with lenalidomide and isatuximab. The study aims to determine if the experimental treatment is not worse than the standard treatment in achieving a state where no minimal residual disease (MRD) is detected, which means that the cancer is not detectable in the body, at week 40 of the study.

The study will monitor participants over a period of time to assess the effectiveness of the treatments and any side effects that may occur. The goal is to find the best treatment approach for managing multiple myeloma and improving patient outcomes. Participants will be closely observed to ensure their safety and to gather data on how well the treatments work in reducing or eliminating the cancer.

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

    Upon joining the study, the patient will begin the initial treatment phase. This phase involves receiving a combination of medications to treat multiple myeloma.

    The medications include bortezomib, administered subcutaneously, lenalidomide taken orally, isatuximab given through intravenous infusion, and dexamethasone taken orally and intravenously.

    The patient will undergo 6 cycles of this treatment combination, known as I-VRD, which stands for isatuximab, lenalidomide, bortezomib, and dexamethasone.

  2. Step 2

    Maintenance therapy

    Following the initial treatment phase, the patient will enter the maintenance therapy phase.

    During this phase, the patient will continue to receive lenalidomide and isatuximab to help maintain the response achieved during the initial treatment.

    The maintenance therapy is designed to be less intensive and aims to prolong the benefits of the initial treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment will be closely monitored.

    Regular assessments will be conducted to evaluate the effectiveness of the treatment and to check for any side effects.

    The patient will be required to attend scheduled visits for these assessments, which may include blood tests, imaging studies, and other evaluations as necessary.

  4. Step 4

    End of trial

    The trial is expected to conclude by September 2028.

    At the end of the trial, the patient's overall response to the treatment will be assessed, and further recommendations for care will be provided based on the outcomes observed during the study.

Who can join the trial?

15 criteria

  • Must be newly diagnosed with **Multiple Myeloma** and have not received treatment for it yet.
  • Must have symptoms of **Multiple Myeloma** as defined by specific medical criteria, such as high calcium levels, kidney issues, low red blood cell count, bone damage, or specific findings in bone marrow or imaging tests.
  • Must have adequate blood vessel access for a procedure called **leukapheresis**, which involves collecting white blood cells.
  • **Men** must agree to use birth control during the study and for at least 5 months after the last dose of a study drug called **isatuximab**. They must also agree not to donate sperm during this time.
  • **Women** must not be pregnant or breastfeeding. If they can have children, they must have a negative pregnancy test before starting the study and regularly during the study. They must use effective birth control during the study and for at least 5 months after the last dose of **isatuximab**.
  • Must agree not to donate blood while taking a study drug called **lenalidomide** and for at least 5 months after the last dose.
  • Must agree not to share **lenalidomide** with anyone and to return any unused capsules to the study team.
  • Must have a certain level of measurable disease, which means having specific levels of proteins in the blood or urine that indicate **Multiple Myeloma**.
  • Must be in **R-ISS stage I**, which is a specific stage of **Multiple Myeloma**.
  • Must have a standard gene expression pattern based on a specific test called **SKY92 GEP assay**.
  • Must be between **18 and 70 years old** at the time of signing the consent form.
  • Must be able to follow the study schedule and requirements according to the study doctor's opinion.
  • Must have a **WHO performance status** of 0-2, which is a measure of general well-being and ability to carry out daily activities. A status of 2 is allowed only if it is due to **Multiple Myeloma** and not other health conditions.
  • Must be able to understand and willing to sign a written consent form before any study-specific procedures.
  • Must be suitable for high-dose **melphalan** treatment and stem cell retransfusion, which are specific treatments for **Multiple Myeloma**.

Who cannot join the trial?

11 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who have had another type of cancer within the last 5 years, except for skin cancer that is not melanoma.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have received another investigational drug within the last 30 days.
  • Patients with known allergies to the study medication or its ingredients.
  • Patients with severe heart disease.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

  • Isatuximab

    is a type of medication known as a monoclonal antibody. It works by targeting a specific protein on the surface of cancer cells, which helps the immune system to recognize and destroy these cells. In this trial, isatuximab is used to help treat multiple myeloma, a type of blood cancer, by working alongside other medications to improve the effectiveness of the treatment.

  • Lenalidomide

    is a medication that helps the immune system fight cancer. It works by stopping the growth of cancer cells and by helping the body’s immune system to attack the cancer. In this trial, lenalidomide is used as part of the treatment plan for multiple myeloma, both during the initial treatment phase and as a maintenance therapy to help keep the cancer from coming back.

  • 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 in combination with other medications to treat multiple myeloma, helping to reduce the number of cancer cells in the body.

  • Dexamethasone

    is a type of steroid medication that helps reduce inflammation and suppress the immune system. In the context of this trial, dexamethasone is used to help enhance the effects of other cancer treatments and to manage some of the symptoms associated with multiple myeloma, such as swelling and pain.

What is already known about the treatment

  • Isatuximab

    Isatuximab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. The main therapeutic use of isatuximab is to help the immune system target and destroy cancer cells. At the molecular level, it works by binding to a specific protein on the surface of cancer cells, which helps the immune system recognize and attack these cells. Isatuximab is classified as a monoclonal antibody, a type of drug designed to target specific proteins in the body.

  • 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. The primary therapeutic indication for lenalidomide is to slow the growth of cancer cells and enhance the immune system's ability to fight cancer. It works at the molecular level by affecting the immune system and inhibiting the growth of blood vessels that tumors need to grow. Lenalidomide is classified as an immunomodulatory drug, which means it modifies the immune response.

  • Bortezomib

    Bortezomib is administered via injection, either under the skin or directly into a vein. It is an established treatment for multiple myeloma and is frequently mentioned in medical literature. The main therapeutic use of bortezomib is to disrupt the growth of cancer cells. It works by inhibiting a protein complex inside cells called the proteasome, which leads to the accumulation of proteins that can cause cancer cells to die. Bortezomib is classified as a proteasome inhibitor, a type of drug that blocks the action of proteasomes.

  • Dexamethasone

    Dexamethasone is taken orally in tablet form or can be given as an injection. It is commonly used in the treatment of multiple myeloma and is well-documented in medical literature. The main therapeutic use of dexamethasone is to reduce inflammation and suppress the immune system, which can help control cancer symptoms and enhance the effectiveness of other cancer treatments. At the molecular level, it works by mimicking the effects of hormones produced by the adrenal glands, which helps reduce inflammation and immune responses. Dexamethasone is classified as a corticosteroid, a type of steroid hormone.

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. The disease begins when abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As it progresses, these abnormal cells crowd out healthy blood cells, causing symptoms such as bone pain, frequent infections, and anemia. Over time, the disease can lead to bone damage, kidney problems, and a weakened immune system. The progression of Multiple Myeloma is typically slow, but it can vary greatly between individuals. The disease is characterized by periods of stability and periods of active disease, which may require different management strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500453-16-00Protocol codeUZL22_01Estimated enrolment78 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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