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Study of isatuximab and pegenzileukin combination treatment for patients with relapsed or refractory multiple myeloma who previously received anti-CD38 and anti-BCMA therapy

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Multiple Myeloma that has returned or become resistant to previous treatments. Multiple Myeloma is a type of blood cancer that affects plasma cells, which are cells in the bone marrow that help fight infections. The study will test a combination of two medications: isatuximab and pegenzileukin, which will be given through intravenous infusion (delivery directly into a vein).

The purpose of this research is to evaluate how well these medications work together in treating patients whose cancer has previously been treated with other therapies. The study is divided into two parts. The first part will determine the right dose of the medications when used together, while the second part will test how effective this combination is in treating the cancer.

During the study, participants will receive both medications through regular infusions. The treatment will continue as long as it appears to be helping and the side effects are manageable. Throughout the study, doctors will monitor participants' health status and how well the cancer responds to treatment. They will also assess how the treatment affects participants' quality of life.

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

    Initial treatment phase

    You will receive two medications through intravenous infusion (directly into your vein):

    - Isatuximab (solution for infusion)

    - Pegenzileukin (concentrate solution for infusion)

    This combination therapy is designed for patients with relapsed or refractory multiple myeloma (a type of blood cancer that has returned or did not respond to previous treatments)

  2. Step 2

    Treatment monitoring phase

    Your response to the treatment will be measured through regular blood tests that check:

    - Levels of specific proteins in your blood (M protein)

    - Levels of specific proteins in your urine

    - Levels of free light chains (specific components in your blood)

  3. Step 3

    Quality of life assessments

    You will be asked to complete several questionnaires to assess your quality of life:

    - General cancer-related quality of life assessment

    - Multiple myeloma specific assessment

    - Assessment of treatment side effects

    - Rating of your condition severity and changes in your health

  4. Step 4

    Safety monitoring

    Throughout the study, you will be monitored for:

    - Any side effects from the treatment

    - Your body's response to the medications

    - The concentration of medications in your body

    Regular health checks will be performed to ensure your safety during the trial

  5. Step 5

    Long-term follow-up

    The study will continue monitoring your progress to assess:

    - How long the treatment response lasts

    - How long you remain free from disease progression

    - Your overall survival

    The total duration of the study is planned from September 2023 to September 2028

Who can join the trial?

8 criteria

  • Must be at least 18 years old
  • Must have a good physical condition, measured by ECOG performance status of 0-1 (ability to perform daily activities with minimal limitations)
  • Must have multiple myeloma that has returned or not responded to at least 2 previous treatments, including specific medications called proteasome inhibitors and immunomodulatory drugs
  • Must have measurable disease that can be monitored through at least one of these tests:
    • Blood test showing protein levels of 0.5 g/dL or higher
    • Urine test showing protein levels of 200 mg or more in 24 hours
    • Blood test showing specific light chain proteins at 10 mg/dL or higher with abnormal protein ratios
    • Must agree to use birth control methods if able to have children
    • For specific study group (Substudy 04): Must have previously received at least 2 treatment cycles with specific medications that target CD38 and BCMA proteins (if available)

Who cannot join the trial?

14 criteria

  • Active systemic infections (infections affecting multiple parts of the body)
  • HIV infection (human immunodeficiency virus) or active hepatitis B or C
  • Other primary cancers that require active treatment
  • Significant heart conditions including heart failure or recent heart attack (within 6 months)
  • Severe kidney dysfunction requiring dialysis
  • Known allergic reactions to similar medications
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Major surgery within 4 weeks before starting the study
  • Serious psychiatric conditions that could interfere with study compliance
  • Blood disorders not related to multiple myeloma
  • Inability to take oral medications
  • History of other medical conditions that could interfere with study participation
  • Use of prohibited medications or treatments
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Investigated drugs

  • Isatuximab

    is a medication that targets a specific protein called CD38 on the surface of multiple myeloma cancer cells. It is used to treat patients with multiple myeloma that has returned or stopped responding to previous treatments. It works by helping the immune system recognize and destroy cancer cells.

  • Pegenzileukin

    is an experimental medication designed to stimulate and enhance the immune system's ability to fight cancer. It works by activating specific immune cells that can help combat multiple myeloma cells.

  • Dexamethasone

    is a steroid medication commonly used in multiple myeloma treatment. It helps reduce inflammation and can enhance the effectiveness of other cancer treatments. It also helps manage various symptoms associated with cancer and its treatment.

What is already known about the treatment

  • Isatuximab

    A monoclonal antibody medication administered through intravenous infusion, specifically designed to target CD38 proteins found on multiple myeloma cells. This targeted therapy is currently approved for treating relapsed or refractory multiple myeloma in combination with other medications, working by binding to cancer cells and triggering their destruction through multiple immune system mechanisms. Isatuximab belongs to the class of immunotherapy drugs and has shown significant effectiveness in clinical trials for patients who have received previous multiple myeloma treatments.

  • Pegenzileukin

    An investigational immunotherapy drug administered through intravenous infusion, designed as a modified interleukin-2 (IL-2) molecule. This novel agent is being studied in clinical trials for various cancers, including multiple myeloma, working by selectively activating and expanding specific immune cells to enhance the body's natural anti-tumor response. It belongs to the class of cytokine-based immunotherapies and is being evaluated in combination with other treatments to potentially improve outcomes for patients with relapsed or refractory multiple myeloma.

Investigated diseases

  • Multiple Myeloma

    A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells interfere with the production of normal blood cells and can damage bones. The disease often causes bone pain, especially in the spine and ribs, and can lead to frequent infections, fatigue, and weakness. Multiple myeloma typically progresses gradually, with periods of active disease alternating with periods of remission.

  • Cancer

    A disease characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells divide rapidly and can invade nearby tissues, potentially spreading to other parts of the body through the blood and lymph systems. Cancer cells develop due to damage or changes to DNA, which can be caused by various environmental and genetic factors. The disease can develop in almost any organ or tissue and typically forms solid tumors, except in blood cancers.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514990-23-00Protocol codeACT16482-04Estimated enrolment51 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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