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Study on Isatuximab, Carfilzomib, and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

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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 type of cancer known as relapsed and/or refractory multiple myeloma. This condition occurs when multiple myeloma, a cancer of the plasma cells in the bone marrow, returns after treatment or does not respond to treatment. The study is investigating a treatment combination that includes isatuximab, carfilzomib, and dexamethasone. Isatuximab, also known by its code name SAR650984, is given as a solution for injection under the skin. Carfilzomib is administered as a solution for infusion into a vein, and dexamethasone is provided in tablet form or as an injection.

The purpose of the study is to evaluate the effectiveness of this combination treatment. Participants will receive the treatment over a period of time, and their response to the treatment will be monitored. The study will also look at how participants feel about the treatment method, particularly the use of a special device called the On Body Delivery System (OBDS) for administering isatuximab. This device is a single-use, wearable system that delivers the medication under the skin.

Throughout the study, researchers will observe various aspects of the treatment, such as the overall response rate, any side effects, and the duration of the response. The study aims to provide valuable information on how well this treatment combination works for people with relapsed and/or refractory multiple myeloma, and how it affects their quality of life. Participants' experiences and satisfaction with the treatment will also be assessed through questionnaires. The study is expected to continue until December 2026.

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

    Joining the study

    Upon joining the study, a diagnosis of multiple myeloma is confirmed. Eligibility is based on specific criteria, including previous treatments and measurable disease markers.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of medications: isatuximab, carfilzomib, and dexamethasone.

    Isatuximab is administered subcutaneously, which means it is injected under the skin.

    Carfilzomib is given intravenously, meaning it is delivered directly into a vein.

    Dexamethasone is taken orally in tablet form.

  3. Step 3

    Treatment schedule

    The treatment is organized in cycles. Each cycle lasts for a specific period, during which the medications are administered according to a set schedule.

    The frequency and dosage of each medication are determined by the study protocol and may vary based on individual response and tolerance.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment. This includes blood tests, imaging studies, and other evaluations as required.

    The primary goal is to evaluate the overall response rate to the treatment combination.

  5. Step 5

    Completion of treatment

    The study is expected to continue until December 2026. Participation may end earlier based on individual circumstances or study findings.

    Upon completion, final assessments are conducted to evaluate the overall effectiveness and any long-term effects of the treatment.

Who can join the trial?

8 criteria

  • Participants must have a documented diagnosis of multiple myeloma (MM), which is a type of cancer.
  • Participants must have a measurable disease, which means they need to have certain levels of specific proteins in their blood or urine. This includes:
    • Serum M-protein of at least 0.5 grams per deciliter (g/dL), measured using a test called serum protein immunoelectrophoresis.
    • Urine M-protein of at least 200 milligrams per 24 hours, measured using a test called urine protein immunoelectrophoresis.
    • Serum free light chain (FLC) assay: Involved FLC assay of at least 10 milligrams per deciliter (mg/dL) and an abnormal serum FLC ratio, which is less than 0.26 or more than 1.65.
    • Participants must have relapsed and/or refractory MM, meaning the disease has returned or is not responding to treatment, with at least one prior line of therapy and no more than three prior lines of therapy.
    • Female participants must not be pregnant or breastfeeding. If they are of childbearing potential, they must agree to practice complete abstinence or use approved contraception methods.
    • Male participants must agree to practice true abstinence or use approved contraception methods while receiving study treatment, during dose interruptions, and for at least five months after stopping the study treatment, even if they have had a successful vasectomy.
    • Participants must be capable of giving signed informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not experienced a return or worsening of their multiple myeloma after treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications.
  • Patients who have had a recent infection that requires treatment.
  • Patients who have received certain treatments for their cancer recently.
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Investigated drugs

  • Isatuximab

    is a medication used in this trial to treat multiple myeloma, a type of blood cancer. It is administered under the skin (subcutaneously) and works by targeting and binding to a specific protein on the surface of cancer cells, helping the immune system to destroy them.

  • Carfilzomib

    is another medication used in the trial for treating multiple myeloma. It is a type of drug known as a proteasome inhibitor, which helps to stop the growth of cancer cells by interfering with their ability to break down proteins.

  • Dexamethasone

    is a steroid medication included in the trial. It is used to reduce inflammation and suppress the immune system, which can help enhance the effectiveness of other cancer treatments and manage symptoms associated with multiple myeloma.

What is already known about the treatment

  • Isatuximab

    Isatuximab is administered subcutaneously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma, a type of cancer. It is an investigational medication, meaning it is still under research and not yet fully approved for widespread use. 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 therapy designed to interfere with cancer cell growth.

  • Carfilzomib

    Carfilzomib is given intravenously and is used in combination with other medications to treat relapsed or refractory multiple myeloma. It is an approved medication and is well-documented in medical literature for its role in cancer treatment. Carfilzomib works by inhibiting proteasomes, which are structures inside cells that break down proteins. By blocking these proteasomes, carfilzomib causes an accumulation of proteins in cancer cells, leading to cell death. It is classified as a proteasome inhibitor, a type of chemotherapy.

  • Dexamethasone

    Dexamethasone is an oral or intravenous medication used in combination with other drugs to treat relapsed or refractory multiple myeloma. It is a well-established medication in medical practice and literature, known for its anti-inflammatory and immunosuppressant properties. Dexamethasone works by mimicking the effects of hormones produced by the adrenal glands, reducing inflammation and modifying the body's immune response. It is classified as a corticosteroid, which is often used to manage symptoms and enhance the effectiveness of cancer treatments.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of 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 bone damage, anemia, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and kidney problems due to the accumulation of abnormal proteins produced by the cancer cells. Relapsed or refractory multiple myeloma refers to the condition when the disease returns after treatment or does not respond to standard therapies. The progression of the disease can vary, with some patients experiencing slow development of symptoms, while others may have a more aggressive course.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508870-27-00Protocol codeACT17453Estimated enrolment124 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).