This clinical trial is focused on studying a condition known as Myelodysplastic Syndrome (MDS), which affects the blood and bone marrow, leading to anemia and the need for red blood cell (RBC) transfusions. The study will use a treatment called Luspatercept, also known by its code name BMS-986346 / ACE-536. Luspatercept is a medication that is given as an injection under the skin and is designed to help reduce the need for RBC transfusions in people with certain types of MDS.
The purpose of this study is to evaluate how effective and safe Luspatercept is when started at the highest approved dose for treating anemia in patients with lower-risk MDS who require RBC transfusions. Participants in the study will receive Luspatercept injections and will be monitored to see if they can achieve independence from RBC transfusions, meaning they no longer need them, along with an increase in their hemoglobin levels, which is a measure of the amount of oxygen-carrying protein in the blood.
The study will take place over a period of time, with participants receiving treatment and being observed for changes in their need for transfusions and any side effects they may experience. The main goal is to see if participants can go without needing transfusions for at least eight weeks while also having an increase in hemoglobin levels. The study will also look at how many RBC units are needed over certain periods and the time it takes for participants to achieve transfusion independence. Safety will be closely monitored by tracking any adverse events, which are unwanted effects that may occur during the study.



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