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Study on Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone for Newly Diagnosed High-Risk Multiple Myeloma Patients

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 testing a combination of treatments to see how effective they are in treating patients who have been newly diagnosed with high-risk multiple myeloma. The treatments being studied include Isatuximab (also known as SAR650984), Carfilzomib (also known as PR-171), Lenalidomide, and a medication called Dexamethasone. These treatments are given in different forms, such as solutions for infusion, which are administered through a vein, and capsules that are taken orally.

The purpose of the study is to evaluate how well these treatments work together in reducing the presence of cancer cells after a series of treatment cycles. The study is divided into different phases, including induction, consolidation, and maintenance treatments. Induction treatment is the initial phase aimed at reducing the number of cancer cells. Consolidation treatment follows to further decrease cancer cells, and maintenance treatment helps to keep the cancer under control. The study will involve several cycles of these treatments, and the effectiveness will be assessed at various stages.

Participants in the study will receive these treatments over a period of time, with regular monitoring to assess their response to the treatment. The study aims to determine if this combination of treatments can help achieve a state where no cancer cells are detectable, known as MRD negativity. The study will also look at how long patients remain free from disease progression. This research is important for understanding how to better treat high-risk multiple myeloma and improve outcomes for patients with this condition.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction phase

    The induction phase involves the administration of several medications to treat multiple myeloma. The medications include isatuximab, carfilzomib, lenalidomide, and dexamethasone.

    Isatuximab is given as an intravenous infusion. Carfilzomib is also administered through intravenous infusion. Lenalidomide is taken orally in the form of capsules.

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

  2. Step 2

    Consolidation phase

    The consolidation phase follows the induction phase and aims to further reduce the presence of cancer cells.

    This phase includes 10 cycles of the same combination of medications (isatuximab, carfilzomib, lenalidomide, and dexamethasone) for patients eligible for transplant, and 12 cycles for those who are not eligible.

    The goal is to achieve minimal residual disease (MRD) negativity, which indicates a very low level of cancer cells.

  3. Step 3

    Maintenance phase

    The maintenance phase is designed to maintain the response achieved during the previous phases and prevent disease progression.

    During this phase, the treatment regimen may be adjusted based on the patient's response and tolerance to the medications.

    Regular monitoring and follow-up visits will be scheduled to assess the effectiveness of the treatment and manage any side effects.

Who can join the trial?

13 criteria

  • Must have newly diagnosed, untreated, and symptomatic **Multiple Myeloma**. This means the disease is active and causing symptoms.
  • Must have measurable disease, which means the disease can be tracked through specific tests. This includes certain levels of proteins in the blood or urine, or specific findings on an MRI scan.
  • Must have high-risk myeloma, which is determined by specific genetic changes found in the cancer cells or by the stage of the disease.
  • Must be **18 years or older** at the time of signing the consent form.
  • Must be able to follow the study schedule and other requirements according to the doctor's opinion.
  • Must have a **WHO performance status** of 0-3. This is a scale that measures how well a person can perform daily activities. A score of 3 is allowed only if it is due to Multiple Myeloma and not other health issues.
  • Females who can have children must agree not to become pregnant from 28 days before starting the study drug, during the study, and for 150 days after stopping the study drug. They must use two reliable methods of birth control and agree to regular pregnancy tests during this time.
  • Females must agree not to breastfeed during the study and for 30 days after stopping the study drug.
  • Males must agree to use a latex condom during any sexual contact with females who can have children while in the study and for 150 days after stopping the study drug, even if they have had a vasectomy.
  • Males must agree not to donate semen or sperm while on the study drug and for 150 days after stopping the study drug.
  • All participants must agree not to donate blood while on the study drug and for 28 days after stopping the study drug.
  • All participants must agree not to share their medication with others.
  • All participants must follow the requirements of the **Lenalidomide Pregnancy Prevention Plan**, which is a plan to prevent pregnancy while taking a specific study drug.
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Investigated drugs

  • Isatuximab

    This medication is used to help the immune system attack and destroy cancer cells. It is a type of monoclonal antibody that targets specific proteins on the surface of cancer cells, making it easier for the immune system to find and kill them.

  • Carfilzomib

    This is a cancer treatment that works by blocking certain proteins in cancer cells, which leads to the death of these cells. It is often used in combination with other medications to treat multiple myeloma.

  • Lenalidomide

    This medication helps the immune system fight cancer and also stops the growth of cancer cells. It is used to treat multiple myeloma and works by affecting the immune system and the growth of blood vessels in tumors.

  • Dexamethasone

    This is a type of steroid that reduces inflammation and helps control the immune system. In cancer treatment, it is used to help reduce side effects of other medications and to help kill cancer cells.

What is already known about the treatment

  • Isatuximab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. It is an investigational drug that is not yet fully approved for widespread use but shows promise in medical literature. 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.

  • Carfilzomib

    Administered through intravenous infusion, Carfilzomib is used in the treatment of multiple myeloma and is part of ongoing clinical trials to assess its efficacy in combination therapies. It is an approved medication in the medical community, known for its role in inhibiting proteasomes, which are enzyme complexes that break down proteins in cells. By blocking these proteasomes, Carfilzomib causes an accumulation of proteins in cancer cells, leading to cell death. It belongs to the pharmacological class of proteasome inhibitors.

  • Lenalidomide

    Taken orally, Lenalidomide is a medication used in the treatment of multiple myeloma and is being evaluated in clinical trials for its effectiveness in combination with other drugs. It is well-established in medical practice and literature, known for its ability to modulate the immune system and inhibit the growth of cancer cells. Lenalidomide works by affecting the immune response and directly attacking cancer cells, and it is classified as an immunomodulatory agent.

  • Dexamethasone

    This medication is administered orally or intravenously and is commonly used in the treatment of multiple myeloma, often in combination with other drugs. It is a well-known and widely used corticosteroid in medicine, recognized for its anti-inflammatory and immunosuppressant properties. Dexamethasone works by reducing inflammation and suppressing the immune system, helping to manage symptoms and enhance the effectiveness of other cancer treatments. It is classified as a corticosteroid.

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, anemia, and kidney problems. As the disease progresses, it can cause bones to become weak and more prone to fractures. Patients may also experience frequent infections due to a weakened immune system. Over time, the accumulation of abnormal proteins produced by the cancerous cells can lead to organ damage. The progression of Multiple Myeloma varies among individuals, with periods of stability and active disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511791-32-00Protocol codeGMMG-CONCEPTEstimated enrolment246 patientsSponsorUniversity Medical Center Hamburg-Eppendorf

sourced from the EU Clinical Trials Register and site verification

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