Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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).

Official Title

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD): The "ELEMENT-MDS" Trial

Keywords

Myelodysplastic Syndromes, Luspatercept, BMS-986346, ACE-536, Myelodysplastic Syndrome, Epoetin alfa, Erythropoietin stimulating agent (ESA), Myelodysplastic Syndromes (MDS), Anaemia, Preleukemia, Anemia, Syndrome

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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:.

    i) < 5% blasts in bone marrow and < 1% blasts in peripheral blood.

  • Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
  • 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:.

    i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.

  • Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.

You CAN'T join if...

  • 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.
  • Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
  • Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • Local Institution - 0258 not yet accepting patients
    Los Angeles California 90095 United States
  • Local Institution - 0095 withdrawn
    Fresno California 93703 United States
  • Community Cancer Institute accepting new patients
    Clovis California 93611 United States
  • Compassionate Cancer Care Medical Group accepting new patients
    Fountain Valley California 92708 United States
  • Local Institution - 0247 not yet accepting patients
    Orange California 92868 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States
  • John Muir Medical Center - Concord Campus accepting new patients
    Concord California 94520 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT05949684
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated