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Study on the Long-Term Safety of Isatuximab for Adults with Multiple Myeloma Benefiting from Isatuximab Therapy

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 the long-term safety of a treatment called isatuximab for patients with multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is designed for patients who have previously participated in earlier phases of research involving isatuximab and have experienced benefits from the treatment. The main goal is to continue monitoring the safety of isatuximab when used alone or in combination with other treatments.

Participants in this study will continue to receive isatuximab as they did in their previous study. The treatment will be administered either as a single therapy or alongside other medications, depending on what was used in the earlier study. The study will track any new side effects or health issues that arise during the treatment period. This will help researchers understand the long-term effects of isatuximab and ensure it remains safe for patients who continue to benefit from it.

The study will last for several years, allowing researchers to gather comprehensive data on the safety of isatuximab over an extended period. This information is crucial for determining the best ways to use isatuximab in treating multiple myeloma and ensuring that patients receive the most effective and safe care possible. Participants will be closely monitored by their healthcare providers throughout the study to ensure their well-being and to address any concerns that may arise during the treatment.

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

    Joining the study

    Upon joining the study, the participant must be at least 18 years old and have completed a previous study involving isatuximab.

    The participant should still be receiving isatuximab and benefiting from it, as determined by the treating physician.

  2. Step 2

    Treatment administration

    The study involves the administration of isatuximab, either alone or in combination with other medications.

    The medication isatuximab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

  3. Step 3

    Monitoring and safety assessment

    Throughout the study, the safety of isatuximab will be monitored closely.

    Participants will be observed for any adverse effects that may arise from the treatment.

  4. Step 4

    Completion of the study

    The study is expected to continue until January 21, 2027.

    Participants will remain in the study as long as they continue to benefit from the treatment and meet the necessary criteria.

Who can join the trial?

5 criteria

  • The participant must be at least 18 years old, or the legal age of consent in the area where the study is happening, when they sign the consent form.
  • The participant must have been part of a previous Phase 1, 2, or 3 study that tested **isatuximab** alone or with other treatments, and all the study goals must have been completed.
  • The participant must still be receiving **isatuximab** when the previous study ends, and they must be benefiting from it, either alone or with other treatments, as decided by their doctor. They must also meet the requirements to start another round of treatment as described in the previous study. If they are not receiving **isatuximab** at the end of the previous study and cannot get the treatment locally, they may still be included.
  • Participants must use two methods of birth control if they are male or female. Female participants must not be pregnant or breastfeeding. Male participants must not donate sperm.
  • The participant must be able to give signed consent, meaning they understand and agree to take part in the study.

Who cannot join the trial?

8 criteria

  • Patients who have not been previously treated with **isatuximab**. Isatuximab is a type of medication used in cancer treatment.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients with certain medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are pregnant or breastfeeding, as the study may involve risks to the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients with severe health issues that could affect their ability to participate safely.
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Investigated drugs

Isatuximab is a medication used in the treatment of multiple myeloma, a type of blood cancer. It works by targeting and binding to a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this clinical trial, isatuximab is being studied to evaluate its long-term safety when used alone or in combination with other treatments for patients who have previously benefited from it in earlier studies.

What is already known about the treatment

Isatuximab – Isatuximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating multiple myeloma, a type of cancer. The medication works by targeting 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 cancer therapy.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. As cancer progresses, it can metastasize, meaning it spreads to other parts of the body through the blood or lymphatic system. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors. Some cancers grow slowly and may not cause symptoms for a long time, while others can be aggressive and rapidly affect health. Understanding the specific type of cancer is crucial for determining its behavior and potential impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507180-19-00Protocol codeLTS17704Estimated enrolment66 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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