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ACTIVE NOT RECRUITING

NCT05949684

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

402

Start Date

2023-10-24

Completion Date

2031-05-30

Last Updated

2026-06-30

Healthy Volunteers

Conditions

Myelodysplastic Syndromes

Interventions

BIOLOGICAL

Luspatercept

Specified dose on specified days

BIOLOGICAL

Epoetin Alfa

Specified dose on specified days

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 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. 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (144)

Local Institution - 0070

Clovis, California, United States

Local Institution - 0179

Fountain Valley, California, United States

Local Institution - 0211

Los Alamitos, California, United States

Local Institution - 0258

Los Angeles, California, United States

Local Institution - 0247

Orange, California, United States

Local Institution - 0209

Oxnard, California, United States

Local Institution - 0183

Walnut Creek, California, United States

Local Institution - 0227

Hartford, Connecticut, United States

Local Institution - 0173

New Haven, Connecticut, United States

Halifax Health Medical Center

Daytona Beach, Florida, United States

Local Institution - 0202

Fort Myers, Florida, United States

Local Institution - 0180

Jacksonville, Florida, United States

Local Institution - 0224

Margate, Florida, United States

Local Institution - 0163

Plantation, Florida, United States

Local Institution - 0201

St. Petersburg, Florida, United States

Local Institution - 0238

Tamarac, Florida, United States

Local Institution - 0106

Tampa, Florida, United States

Local Institution - 0240

Honolulu, Hawaii, United States

Local Institution - 0272

Chicago, Illinois, United States

Local Institution - 0184

Skokie, Illinois, United States

Local Institution - 0270

Dyer, Indiana, United States

Local Institution - 0191

Baton Rouge, Louisiana, United States

Local Institution - 0044

Covington, Louisiana, United States

Local Institution - 0007

Bethesda, Maryland, United States

Local Institution - 0222

Saint Louis Park, Minnesota, United States

Local Institution - 0128

Hattiesburg, Mississippi, United States

Local Institution - 0212

Hackensack, New Jersey, United States

Local Institution - 0206

Columbus, Ohio, United States

Local Institution - 0174

Knoxville, Tennessee, United States

Local Institution - 0228

Houston, Texas, United States

Local Institution - 0236

Richmond, Virginia, United States

Local Institution - 0229

Roanoke, Virginia, United States

Local Institution - 0203

Kennewick, Washington, United States

Local Institution - 0010

Buenos Aires, Argentina

Local Institution - 0009

Buenos Aires, Argentina

Local Institution - 0012

Buenos Aires, Argentina

Local Institution - 0071

Blacktown, New South Wales, Australia

Local Institution - 0113

Camperdown, New South Wales, Australia

Local Institution - 0254

Coffs Harbour, New South Wales, Australia

Local Institution - 0246

Gold Coast, Queensland, Australia

Local Institution - 0054

Clayton, Victoria, Australia

Local Institution - 0052

Heidelberg, Victoria, Australia

Local Institution - 0059

Fortaleza, Ceará, Brazil

Local Institution - 0101

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0056

Rio de Janeiro, Brazil

Local Institution - 0003

São Paulo, Brazil

Local Institution - 0049

Calgary, Alberta, Canada

Local Institution - 0112

Vancouver, British Columbia, Canada

Local Institution - 0050

London, Ontario, Canada

Local Institution - 0017

Toronto, Ontario, Canada

Local Institution - 0280

Santiago, Santiago Metropolitan, Chile

Local Institution - 0278

Santiago, Santiago Metropolitan, Chile

Local Institution - 0276

Santiago, Santiago Metropolitan, Chile

Local Institution - 0277

Santiago, Santiago Metropolitan, Chile

Local Institution - 0109

Hefei, Anhui, China

Local Institution - 0217

Beijing, Beijing Municipality, China

Local Institution - 0030

Beijing, Beijing Municipality, China

Local Institution - 0223

Chongqing, Chongqing Municipality, China

Local Institution - 0220

Xiamen, Fujian, China

Local Institution - 0266

Shijiazhuang, Hebei, China

Local Institution - 0038

Harbin, Heilongjiang, China

Local Institution - 0194

Zhengzhou, Henan, China

Local Institution - 0108

Wuhan, Hubei, China

Local Institution - 0089

Changsha, Hunan, China

Local Institution - 0032

Nanjing, Jiangsu, China

Local Institution - 0083

Suzhou, Jiangsu, China

Local Institution - 0079

Nanchang, Jiangxi, China

Local Institution - 0043

Changchun, Jilin, China

Local Institution - 0048

Shenyang, Liaoning, China

Local Institution - 0111

Qingdao, Shandong, China

Local Institution - 0218

Shanghai, Shanghai Municipality, China

Local Institution - 0216

Xi’an, Shanxi, China

Local Institution - 0075

Chengdu, Sichuan, China

Local Institution - 0103

Tianjin, Tianjin Municipality, China

Local Institution - 0029

Hangzhou, Zhejiang, China

Local Institution - 0281

Ningbo, Zhejiang, China

Local Institution - 0033

Wenzhou, Zhejiang, China

Local Institution - 0147

Medellín, Antioquia, Colombia

Local Institution - 0152

Valledupar, Cesar Department, Colombia

Local Institution - 0267

Piedecuesta, Santander Department, Colombia

Local Institution - 0149

Montería, Colombia

Local Institution - 0080

Brno, Brno-město, Czechia

Local Institution - 0092

Ostrava, Moravian-Silesian Region, Czechia

Local Institution - 0090

Prague, Czechia

Local Institution - 0011

Nice, Alpes-Maritimes, France

Local Institution - 0016

Pessac, Aquitaine, France

Local Institution - 0019

Tours, Indre-et-Loire, France

Local Institution - 0116

La Tronche, Isère, France

Local Institution - 0165

Vandœuvre-lès-Nancy, Lorraine, France

Local Institution - 0269

Angers, Maine-et-Loire, France

Local Institution - 0248

Villejuif, Val-de-Marne, France

Local Institution - 0015

Paris, France

Local Institution - 0140

Toulouse, France

Local Institution - 0261

Erding, Bavaria, Germany

Local Institution - 0259

Münster, North Rhine-Westphalia, Germany

Local Institution - 0168

Koblenz, Rhineland-Palatinate, Germany

Local Institution - 0171

Leipzig, Saxony, Germany

Local Institution - 0251

Jena, Thuringia, Germany

Local Institution - 0169

Berlin, Germany

Local Institution - 0028

Berlin, Germany

And 44 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (144)