ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

Description

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).

Conditions

Myelodysplastic Syndromes

Study Overview

Study Details

Study overview

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).

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

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

Condition
Myelodysplastic Syndromes
Intervention / Treatment

-

Contacts and Locations

Clovis

Community Cancer Institute, Clovis, California, United States, 93611

Concord

John Muir Medical Center - Concord Campus, Concord, California, United States, 94520

Fountain Valley

Compassionate Cancer Care Medical Group, Fountain Valley, California, United States, 92708

Fresno

Local Institution - 0095, Fresno, California, United States, 93703

Los Alamitos

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States, 90720

Los Angeles

Local Institution - 0258, Los Angeles, California, United States, 90095

Orange

Local Institution - 0247, Orange, California, United States, 92868

Oxnard

Ventura County Hematology Oncology Specialists, Oxnard, California, United States, 93030

Fort Collins

Local Institution - 0098, Fort Collins, Colorado, United States, 80528

Hartford

Hartford Hospital (HH), Hartford, Connecticut, United States, 06102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Bristol-Myers Squibb,

    Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

    Study Record Dates

    2030-03-11