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Study on Continuing Elotuzumab Treatment for Patients with Multiple Myeloma from Previous Trials

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What is this trial about?

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

This clinical trial focuses on the treatment of Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study involves the use of a medication called Elotuzumab, which is administered as a solution for infusion. The purpose of the study is to provide Elotuzumab and/or other study drugs to participants who have previously been part of a trial investigating Elotuzumab and are unable to receive the medication through commercial means.

Participants in this study will continue to receive Elotuzumab and/or other study drugs as they did in their previous trial. The study will monitor the number of participants who receive at least one dose of Elotuzumab or other therapies, as well as the duration of their treatment. Additionally, the study will collect information on any serious adverse events (SAEs), Grade 5 adverse events (AEs), new AEs, and AEs that lead to discontinuation of the treatment. These events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE).

The trial is designed to ensure that participants who have benefited from Elotuzumab in previous studies can continue their treatment. The study will run until the end of 2024, providing ongoing access to the medication for those who need it. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the effects of 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

    Participation in this study is for individuals who have previously been part of a trial involving elotuzumab and are currently benefiting from it.

    Eligibility requires that you are already receiving elotuzumab or other study drugs at the time of signing the consent form.

    Participants must be 18 years or older.

  2. Step 2

    Treatment administration

    Elotuzumab is administered as a solution for infusion, which means it is given through a vein (intravenous use).

    The specific dosage and frequency of administration will be determined based on the previous protocol you participated in.

  3. Step 3

    Monitoring and data collection

    The study will collect data on the number of participants who receive at least one dose of elotuzumab or other study drugs, as well as the duration of treatment.

    Any serious adverse events (SAEs), severe adverse events (Grade 5 AEs), new adverse events, or those leading to discontinuation will be recorded.

    Adverse events and symptoms will be assessed using a standardized grading system.

  4. Step 4

    Study duration

    The estimated end date for the study is December 31, 2024.

    The study began recruiting participants on November 20, 2020.

Who can join the trial?

6 criteria

  • You must have participated in a previous study involving **elotuzumab**. Elotuzumab is a type of medication used in treating certain conditions.
  • The previous study could include studies like HuLuc63-1703, CA204007, CA204009, or CA204011.
  • The doctor must believe that you are benefiting from **elotuzumab** or other study medications based on the previous study.
  • You must be currently receiving **elotuzumab** or other study medications when you sign the consent form to join this study.
  • You must be at least 18 years old or the legal age of adulthood in your area.
  • Both males and females can participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who have not participated in a previous study involving the drug **elotuzumab** cannot join. **Elotuzumab** is a medication used in treating certain types of cancer.
  • Patients who are able to receive the drug **elotuzumab** through regular commercial means are not eligible. This means if you can get the drug outside of the study, you cannot participate.
  • Patients who are part of a vulnerable population are not allowed to join. A vulnerable population includes groups like children, pregnant women, or those unable to make decisions for themselves.
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Investigated drugs

Elotuzumab is a medication used in this clinical trial. It is designed to help the immune system target and attack certain cancer cells. Participants in this trial have previously been involved in studies with elotuzumab and will continue to receive it as part of their treatment. The goal is to provide ongoing access to this medication for those who cannot obtain it through commercial means.

What is already known about the treatment

Elotuzumab – Elotuzumab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently used in clinical settings and is well-documented in medical literature, particularly for its role in treating multiple myeloma, a type of blood cancer. The main therapeutic indication for elotuzumab is as a treatment for multiple myeloma, often in combination with other medications. At the molecular level, elotuzumab works by targeting a protein called SLAMF7 on the surface of myeloma cells and certain immune cells, enhancing the immune system's ability to attack the cancer cells. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to specifically interact with certain proteins in the body.

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. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones and kidneys. As the disease progresses, it can result in bone pain, fractures, and anemia due to the crowding out of healthy blood cells. Patients may also experience frequent infections because the immune system is compromised. Over time, the accumulation of these abnormal cells can lead to organ dysfunction and other complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515490-10-00Protocol codeCA204-185Estimated enrolment45 patientsSponsorBristol Myers Squibb International Corporation

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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).