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Study Comparing Isatuximab with Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Eligible for Stem Cell 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 blood cancer called multiple myeloma, which affects plasma cells in the bone marrow. The study is comparing two treatment combinations for patients who have been newly diagnosed with multiple myeloma and are eligible for a procedure called autologous stem cell transplantation. The first treatment combination includes four medications: Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone. The second combination includes Carfilzomib, Lenalidomide, and Dexamethasone without Isatuximab. The purpose of the study is to see which combination is more effective in treating the disease.

Participants in the study will receive one of the two treatment combinations. The study will last for a period of up to 24 months. During this time, participants will have regular check-ups and tests to monitor their health and the effectiveness of the treatment. The study aims to find out how well the treatments work in reducing the amount of cancer cells in the body, which is known as achieving minimal residual disease negativity. This means that the number of cancer cells is so low that they cannot be detected using standard tests.

The study will also look at other important factors, such as the overall survival of participants, the time it takes for the disease to progress, and the quality of life of the participants. By comparing these two treatment combinations, researchers hope to find the best approach for treating newly diagnosed multiple myeloma in patients who are eligible for stem cell transplantation. The study is expected to continue until April 2030.

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 informed about the trial's objectives and procedures. Written consent is required before any study-specific activities begin.

  2. Step 2

    Induction phase

    During this phase, the patient will receive a combination of medications to treat multiple myeloma. The medications include isatuximab (administered intravenously), carfilzomib (administered intravenously), lenalidomide (administered orally in capsule form), and dexamethasone (administered orally as a solution).

    The specific dosages and frequency of administration will be determined by the healthcare provider based on the patient's condition and response to treatment.

  3. Step 3

    Autologous stem cell transplantation (ASCT)

    Following the induction phase, the patient will undergo an autologous stem cell transplantation. This procedure involves collecting the patient's own stem cells, which are then reintroduced into the body after high-dose chemotherapy.

  4. Step 4

    Post-ASCT consolidation treatment

    After the transplantation, the patient will receive consolidation treatment to eliminate any remaining cancer cells. This phase includes the same combination of medications as the induction phase: isatuximab, carfilzomib, lenalidomide, and dexamethasone.

  5. Step 5

    Light consolidation phase

    In this phase, the patient continues to receive treatment with the goal of maintaining remission. The medications used are similar to those in previous phases, with adjustments made as necessary based on the patient's response.

  6. Step 6

    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.

Who can join the trial?

12 criteria

  • The patient must have been newly diagnosed with **multiple myeloma**, a type of blood cancer.
  • The patient should be eligible for **autologous stem cell transplantation (ASCT)**, a procedure where a patient's own stem cells are used to replace damaged or diseased bone marrow.
  • The patient must be between 18 and 70 years old.
  • The patient should have **monoclonal plasma cells** in the bone marrow that are 10% or more, or have a biopsy-proven **plasmacytoma** (a type of tumor) and meet certain criteria related to calcium, kidney function, anemia, or bone damage.
  • The patient must have a **measurable disease**, which means certain levels of specific proteins in the blood or urine that can be tracked.
  • The patient should have a life expectancy of at least 3 months.
  • The patient must have an **ECOG status** of 2 or less, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • The patient must have certain **clinical laboratory values** within specific ranges, such as liver function tests, blood cell counts, and kidney function.
  • Females of childbearing potential must follow a **Pregnancy Prevention Plan**, which includes using effective birth control methods and undergoing regular pregnancy tests.
  • Male patients must agree to use contraception if sexually active with females of childbearing potential and refrain from donating sperm for a specified period after treatment.
  • The patient must be willing and able to attend study visits and follow the procedures required by the study.
  • The patient must provide written informed consent, which means they agree to participate in the study after being informed about its details.

Who cannot join the trial?

4 criteria

  • Patients who have not been newly diagnosed with multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is determined by the study organizers based on specific criteria.
  • Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes individuals who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • Isatuximab

    is a medication used in the treatment of multiple myeloma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.

  • Carfilzomib

    is a medication that helps treat multiple myeloma by blocking certain proteins in cancer cells, which leads to their death. It is often used in combination with other medications to enhance its effectiveness.

  • Lenalidomide

    is a medication that modifies the immune system and has anti-cancer effects. It is used to treat multiple myeloma by slowing the growth of cancer cells and helping the immune system attack them.

  • Dexamethasone

    is a type of steroid that reduces inflammation and is used in combination with other medications to treat multiple myeloma. It helps enhance the effects of other cancer treatments and manage symptoms.

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 newly diagnosed multiple myeloma. It is an investigational drug that targets 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 targeted therapy designed to interfere with cancer cell growth.

  • Carfilzomib

    Carfilzomib is given through intravenous infusion and is approved for use in treating multiple myeloma. It works by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, leading to cancer cell death. Carfilzomib is classified as a proteasome inhibitor, a type of drug that disrupts the normal function of cancer cells, causing them to die.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form and is widely used in the treatment of multiple myeloma. It works by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory agent, which helps enhance the body's immune response against cancer.

  • Dexamethasone

    Dexamethasone is administered orally or intravenously and is commonly used in combination with other medications for multiple myeloma. It is a corticosteroid that reduces inflammation and suppresses the immune response, helping to alleviate symptoms and enhance the effectiveness of other cancer treatments. Dexamethasone is classified as a glucocorticoid, which is 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. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to symptoms such as bone pain, frequent infections, and anemia. As the disease progresses, it can cause damage to bones and kidneys, and lead to high levels of calcium in the blood. The abnormal plasma cells produce a protein that can be detected in the blood or urine, which helps in monitoring the disease. Over time, multiple myeloma can lead to complications such as weakened bones, kidney problems, and increased risk of infections. The progression of the disease varies among individuals, with some experiencing slow progression and others more rapid advancement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513422-38-00Protocol codeEMN24Estimated enrolment302 patientsSponsorEmn Trial Office S.r.l. Impresa Sociale

sourced from the EU Clinical Trials Register and site verification

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