Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab

This research is designed for people with multiple myeloma (a blood cancer) who have already taken part in a previous study involving a medicine called elotuzumab. The main aim is to see how long patients continue to take elotuzumab or other supportive treatments after that initial study. Researchers will also be carefully monitoring any side effects that might occur during this period. The medicines involved include Dexamethasone, Lenalidomide, and a specific form of Empliciti. This is a Phase II study, meaning it's exploring how well the treatment works and looking at safety in more detail.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bristol Myers Squibb International Corporation

Enrolment target

Start

14 Aug 2024

Multiple Myeloma

What is this study about?

This study is called an 'extension' study. This means it's for people who have already been part of an earlier research study looking at a drug called elotuzumab for multiple myeloma. Multiple myeloma is a type of cancer that affects certain cells in your bone marrow. This 'extension' study aims to gather more information about the treatment you've been receiving.

The main thing the researchers want to find out is how long patients continue to take elotuzumab or the other treatments that support it. These other treatments might include medicines like Dexamethasone and Lenalidomide, which are commonly used for multiple myeloma. By understanding how long people stay on treatment, doctors can get a better idea of the long-term effectiveness and tolerability of elotuzumab.

Another very important part of this study is to keep a close eye on any side effects. Researchers will be tracking all types of side effects, especially any serious ones, those that lead someone to stop treatment, or any new side effects not seen before. This helps ensure patient safety and builds a complete picture of the treatment's profile.

Key takeaways

This study is for people previously treated with elotuzumab for multiple myeloma.
It aims to understand how long patients continue treatment and track any side effects.
Medicines involved include elotuzumab, Dexamethasone, and Lenalidomide.
All adults (18+) who were in the previous study are potentially eligible.
Your health and any side effects will be carefully monitored during this follow-up period.

Who may be eligible?

To be able to take part in this study, you must have previously participated in an earlier research study that was investigating the drug elotuzumab for multiple myeloma. This current study is a continuation of that previous research.

All adults aged 18 years and older are welcome to be considered, regardless of their sex.

Essentially, if you were in the original elotuzumab study for multiple myeloma, this follow-up study is designed for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I previously taken part in a study investigating elotuzumab for multiple myeloma?
Am I 18 years old or older?
Do I have a diagnosis of multiple myeloma?
Am I currently receiving treatment that includes elotuzumab or related therapies from a previous study?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will mainly involve continuing your current treatment regimen, which may include elotuzumab, Dexamethasone, and Lenalidomide. The study will primarily focus on observing how long you continue taking these medications.

You will need to attend regular appointments where the study team will assess your health and check for any side effects. This involves reporting any new symptoms or changes in your health to the study doctors. They will grade any side effects to understand their severity.

The total duration of your participation will depend on how long you continue to receive the study treatments. There isn't a fixed end date for individuals as long as treatment continues and the study is active. This study does not introduce new treatments but continues to monitor those from a prior study.

Potential risks and benefits

Potential benefits of staying in this study include continued access to your current treatment, which doctors believe may be helping your multiple myeloma. It also contributes valuable information to medical science, which could help future patients. Potential risks include experiencing known or new side effects from the medications, such as those from Dexamethasone, Lenalidomide, or Empliciti. All side effects will be carefully monitored. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania

Common questions

What is the main goal of this study?

The main goal is to see how long people continue taking elotuzumab or other treatments for multiple myeloma after being in an earlier study, and to check for side effects.

Who can join this study?

You can join if you are an adult, 18 or older, and have already been in a previous study using elotuzumab for multiple myeloma.

What medications are involved?

The study involves continuing treatments like elotuzumab (Empliciti), Dexamethasone, and Lenalidomide.

Will I get new treatment in this study?

No, this study is about continuing and monitoring the treatments you were already receiving in a previous study.

What does a 'Phase II' study mean?

Phase II means doctors are further exploring how well the treatment works and closely checking for any side effects in a group of patients.