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) ELEMENT-MDS

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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: i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.
* Participant is not transfusion dependent (NTD) based on IWG2018 criteria
* Participant has never received treatment with an erythropoiesis stimulating agent (ESA)
* 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 mean baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. Mean Hb is defined as the mean of all central/ local/ pretransfusion available Hb measurements during the 16 weeks prior to randomization (with a minimum of 2 measurements at least 1 week apart). Only Hb levels \> 21 days following a transfusion are acceptable. The last measurement must be within 35 days of randomization.

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.
* 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.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Additional Trial Information

Phase 3

Enrollment: 360 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

John Muir Medical Center

Concord, CA

Not Yet Accepting

Compassionate Cancer Care

Fountain Valley, CA

Not Yet Accepting

Ventura County Hematology-Oncology Specialists

Oxnard, CA

Not Yet Accepting

Florida

Florida Cancer Specialists - South - Fort Myers

Fort Myers, FL

Not Yet Accepting

Baptist MD Anderson

Jacksonville, FL

Not Yet Accepting

Napa Research

Pompano Beach, FL

Open and Accepting

Florida Cancer Specialists - North - St. Petersburg North

St. Petersburg, FL

Not Yet Accepting

Illinois

Orchard Healthcare Research Inc. (Dr. Ira Oliff, MD)

Skokie, IL

Not Yet Accepting

Hematology/Oncology of the North Shore

Skokie, IL

Not Yet Accepting

Maryland

American Oncology Partners of Maryland (Bethesda) The Center for Cancer & Blood Disorders - Bethesda

Bethesda, MD

Open and Accepting

Minnesota

Metro-Minnesota Community Oncology Research Consortium (MMCORC)

St. Louis Park, MN

Not Yet Accepting

Mississippi

Hattiesburg Clinic

Hattiesburg, MS

Open and Accepting

Ohio

The Ohio State University Comprehensive Cancer Center The James Cancer Hospital and Solove Research Institute

Columbus, OH

Not Yet Accepting

Tennessee

Tennessee Oncology Memorial Plaza

Chattanooga, TN

Not Yet Accepting

University of Tennessee Medical Center Cancer Institute

Knoxville, TN

Open and Accepting

Washington

Kadlec Clinic Hematology and Oncology

Kennewick, WA

Not Yet Accepting

Fred Hutchinson / University of Washington Cancer Consortium Seattle Cancer Care Alliance (SCCA)

Seattle, WA

Not Yet Accepting
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