Randomized Phase III Study of Luspatercept Alone or Combined with Epoetin Alfa in Lower Risk Myelodysplastic Syndromes Without Ring Sideroblasts in Patients Who Failed or Are Ineligible for ESA

What this Trial Is About

Researchers are studying the combination of luspatercept and erythropoiesis stimulating agents ESA in adults with low-risk myelodysplastic syndromes LR-MDS without ring sideroblasts who have not responded to or cannot use ESA treatments. This trial aims to find the best dose of luspatercept combined with ESA and then compare the combinations effectiveness to luspatercept alone in patients whose disease has not progressed. The study has two parts Part A focuses on finding the optimal dose of luspatercept plus ESA by testing various dosing levels. Part B compares the combination treatment of luspatercept and ESA to luspatercept alone. Luspatercept is given by subcutaneous injection every three weeks, with doses adjusted in Part A. ESA epoetin alfa is also given as a weekly subcutaneous injection at doses determined in Part A. Participants will receive treatment according to their assigned group and be monitored regularly for side effects and treatment response. Researchers will evaluate toxicity early in treatment and measure benefits at 25 weeks. Additional outcomes include response rate at 3 months, response duration up to 24 months, and overall survival up to 30 months. The study includes informed consent, regular visits, laboratory tests, and safety assessments over the course of participation.

Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA