A Phase 3b Study of BMS-986346 in Lower-risk Myelodysplastic Syndrome Participants

Other illness

• A participant will be excluded from the study if they have a secondary MDS, known history of diagnosis of AML, prior allogenic or autologous stem cell transplant, history of allergy or hypersensitivity to study drug components, pregnant, plan to get pregnant or breastfeeding, prior history of malignancies, known significant anemia due to iron, vitamin B12 or folate deficiencies.

• Participants are eligible to be included in the study if all following criteria apply: A) Participant must be 18 years or older, have documented diagnosis of MDS, have an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. For Cohort 1 only: participant must have an endogenous serum erythropoietin (EPO) level of < 500 U/L and no prior ESA treatment. For Cohort 2 only: participant must be refractory or intolerant to prior ESA treatment as defined by any of the following: i) Refractory to prior ESA treatment: Documentation of nonresponse or response that was no longer maintained to prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF). The ESA regimen must have been either: (1) Recombinant human erythropoietin ≥ 40,000 IU/week for at least 8 doses or equivalent; or 1050 mg/kg/week for at least 8 doses or equivalent OR (2) Darbepoetin- darbepoetin alpha ≥ 240 μg every week for at least 12-weeks or equivalent ii) Intolerant to prior ESA treatment: Documentation of discontinuation of prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF), at any time after introduction due to intolerance or an AE. B) And must require RBC transfusion documented by the following criteria: i) Average transfusion requirement of ≥ 1 units of packed RBCs (pRBCs) confirmed for a minimum of 8-weeks immediately prior to first treatment of luspatercept ii) Hb levels at the time of or within 7 days prior to administration of an RBC transfusion must be ≤ 10.0 g/dL in order for the transfusion to be counted towards meeting eligibility criteria. RBC transfusions administered when Hb levels are > 10 g/dL and/or RBC transfusions administered for elective surgery do not qualify as a required transfusion for the purpose of meeting eligibility criteria