A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Ostrava-Poruba, 708 52, Czechia
Baden-Warttemberg, 73557, Germany
Keil, 24105, Germany
Rio Patras, 26500, Greece
Amagasaki-Shi, 660-0892, Japan
Fujisawa-Shi, 251-0052, Japan
Hitachi, Ibaraki, 317-0077, Japan
Kitakyushu-Shi, 806-0034, Japan
Nagaoka-Shi, 940-2108, Japan
Shibuya-ku, 150-8935, Japan
Shimotsuga-gun, 321-0293, Japan
Sittard-Geleen, 6162 BG, Netherlands
Rzwszow, 35-055, Poland
Hwasun-Gun, 58128, South Korea
Changhua City, Changhua, 500, Taiwan
Niaosong District Kaohsiung City, 83301, Taiwan
Headington, Oxford, OX3 7LE, United Kingdom