A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

To join this study, doctors will first check if you have myelodysplastic syndromes (MDS) and if your condition is considered 'very low', 'low', or 'intermediate' risk. This is based on specific criteria that doctors use to classify MDS. An important part of joining is that you must be needing regular red blood cell transfusions. Specifically, you would have received between two and six units of blood every eight weeks for at least two months before the study starts. You also shouldn't have tried treatments like epoetin alfa before.

There are also some reasons why you might not be able to join. For example, if your anemia is caused by other easily treatable things like a lack of iron or vitamins, or if you have certain other serious health problems. You also wouldn't be able to join if you have a known history of acute myeloid leukaemia (AML) or if your blood pressure is not well controlled even with medication. The medical team will check all these carefully with you.

If you decide to take part, you'll be assigned to receive either luspatercept or epoetin alfa. Neither you nor your doctor will get to choose which medicine you receive, and often you won't know which one it is (this is called a 'blinded' study). You'll have regular visits to the clinic for medical check-ups, blood tests, and to receive your study medicine. These visits will help the doctors monitor how you're doing, check your blood counts, and look for any side effects. The total duration of your participation in the study will depend on how you respond to the treatment and the study's design, but it will involve ongoing assessments and follow-up care.