Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

This study is investigating a new medication called Luspatercept. It's for people who have a condition known as Myelodysplastic Syndrome (MDS), specifically the 'lower-risk' kind. MDS affects how your body makes healthy blood cells, and often leads to needing regular blood transfusions. The main goal of this study is to find out if Luspatercept is safe and effective at its usual dose. We want to see if it can help reduce how often people with lower-risk MDS need blood transfusions. By doing this, we hope to improve their quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

106

Start

05 Oct 2023

Estimated completion

30 Dec 2027

Myelodysplastic Syndromes

What is this study about?

This research study is about a medication called Luspatercept, which is being tested for people who have a blood condition called Myelodysplastic Syndrome, or MDS. MDS means your body doesn't produce enough healthy blood cells, which can make you feel very tired and weak. Often, people with MDS need blood transfusions to help their bodies get the red blood cells they need.

Specifically, this study is looking at people who have a 'lower-risk' type of MDS. This means their condition is not as aggressive as some other forms. The study wants to see two main things: first, if Luspatercept is safe to use, and second, if it can help reduce the number of red blood cell transfusions these patients need. Less frequent transfusions could mean better health and less time spent at the hospital for patients. Luspatercept is already approved for some MDS patients, but this study specifically focuses on its impact at a certain dose for this particular group of lower-risk patients.

Understanding if Luspatercept can make a real difference for people with lower-risk MDS who depend on transfusions is very important. It could offer a new way to manage their condition and improve their daily lives. The study aims to gather important information that will help doctors and patients make informed decisions about treatment in the future.

Key takeaways

This study explores Luspatercept for lower-risk MDS.
It aims to reduce the need for blood transfusions.
Participation includes medication and regular check-ups.
Potential benefits include improved blood counts; risks involve possible side effects.
Volunteers can withdraw at any point.

Who may be eligible?

To join this study, you would need to have been diagnosed with a 'lower-risk' type of Myelodysplastic Syndrome (MDS) by your doctor. Your general health and ability to do daily activities should also be reasonably good.

Crucially, you must need regular red blood cell transfusions, as this is a key part of what the study is trying to address. You'll be at least 18 years old, and the study is open to both men and women.

There are also some reasons why you might not be able to join. For example, if your anaemia is caused by something else, like a lack of iron or vitamins, or if you've had a stem cell transplant before. Also, if you have a history of a more aggressive blood cancer called AML, or if your blood pressure isn't well controlled, you might not be suitable. The study team will check all these details carefully with 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.

Do you have a diagnosis of lower-risk Myelodysplastic Syndrome (MDS)?
Do you currently need regular red blood cell transfusions?
Are you 18 years old or older?
Is your general health good enough to participate in a study?
Have you *not* had a stem cell transplant before?
Do you *not* have other specific anaemia causes (like iron deficiency)?
Do you *not* have uncontrolled high blood pressure?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Luspatercept, according to the study plan. This involves regular visits to the clinic for assessments, which might include blood tests, physical examinations, and questions about how you're feeling and any side effects you might be experiencing. The study team will closely monitor your need for blood transfusions. The total duration of your participation and the frequency of visits would be explained in detail by the study staff.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a medication that could help reduce your need for blood transfusions and improve your blood count, possibly feeling better as a result. However, like all medications, Luspatercept can have side effects, and some may be serious. The study team will explain all known risks and monitor you closely. You are always free to leave the study at any time, for any reason, without it affecting your usual care.

Locations (52)

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Los Alamitos, United States
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New Haven, United States
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St. Petersburg, United States
Local Institution - 0056
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Wellington, United States
Local Institution - 0020
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Kansas City, United States
Local Institution - 0025
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Paducah, United States
Local Institution - 0011
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Detroit, United States
Local Institution - 0059
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St Louis, United States
Local Institution - 0058
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Morristown, United States
Local Institution - 0032
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New York, United States
Local Institution - 0054
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Eugene, United States
Local Institution - 0036
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Pittsburgh, United States

Common questions

What is Myelodysplastic Syndrome (MDS)?

MDS is a condition where your bone marrow doesn't make enough healthy blood cells, which can lead to problems like anaemia.

What is Luspatercept?

Luspatercept is a medication being tested to see if it can help improve blood cell production and reduce the need for transfusions in certain MDS patients.

Why is this study only for 'lower-risk' MDS?

Different treatments work for different types of MDS. This study focuses on people with lower-risk MDS to see how this specific medication helps them.

Will I still need blood transfusions during the study?

The goal of the study is to see if Luspatercept can reduce your need for transfusions, but you may still need them while on the study.

What does 'Phase 3' mean for a clinical trial?

Phase 3 means the treatment has already been tested in smaller groups, and now it's being given to a larger group of people to confirm its effectiveness and safety before it can be widely available.