Blood Cancer CA056-025

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

Inclusion Criteria:

  • Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and: < 5% blasts in bone marrow and < 1% blasts in peripheral blood.
  • Participant is not transfusion dependent (NTD).
  • Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
  • Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
  • Participant has symptoms of anemia.
  • Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL.

Exclusion Criteria:

  • Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
  • Participant with known history of diagnosis of AML.

Locations: HH, HOCC

Contacts: Siobhan Reilly 860.696.4958 Siobhan.Reilly@hhchealth.org; Krystal Myers 860.972.5364 Krystal.Myers@hhchealth.org

Sponsor: BMS

Cancer Clinical Research Office