New hope for MDS anemia: luspatercept vs standard care in phase 3 trial

NCT ID NCT05949684

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests whether luspatercept works better than epoetin alfa for treating anemia in adults with a certain type of low-risk MDS who have not needed blood transfusions or prior anemia drugs. About 360 participants will receive one of the two drugs, and researchers will track how many need transfusions over 96 weeks. The goal is to see which drug better prevents the need for regular blood transfusions.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

402 people

The number who actually took part.

Started

Oct 2023

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndromes

Contacts and locations

Locations

Halifax Health Medical Center

Daytona Beach, Florida, 32114, United States
Local Institution - 0003

São Paulo, 05403-000, Brazil
Local Institution - 0007

Bethesda, Maryland, 20817, United States
Local Institution - 0009

Buenos Aires, C1426ANZ, Argentina
Local Institution - 0010

Buenos Aires, C1425DND, Argentina
Local Institution - 0011

Nice, Alpes-Maritimes, 06202, France
Local Institution - 0012

Buenos Aires, CP1280AEB, Argentina
Local Institution - 0015

Paris, 75010, France
Local Institution - 0016

Pessac, Aquitaine, 33600, France
Local Institution - 0017

Toronto, Ontario, M4N 3M5, Canada
Local Institution - 0019

Tours, Indre-et-Loire, 37032, France
Local Institution - 0021

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Local Institution - 0024

Eger, Heves County, 3300, Hungary
Local Institution - 0026

Budapest, 1088, Hungary
Local Institution - 0028

Berlin, 14195, Germany
Local Institution - 0029

Hangzhou, Zhejiang, 310003, China
Local Institution - 0030

Beijing, Beijing Municipality, 100730, China
Local Institution - 0032

Nanjing, Jiangsu, 210029, China
Local Institution - 0033

Wenzhou, Zhejiang, 32500, China
Local Institution - 0038

Harbin, Heilongjiang, 150010, China
Local Institution - 0043

Changchun, Jilin, 130021, China
Local Institution - 0044

Covington, Louisiana, 70433, United States
Local Institution - 0048

Shenyang, Liaoning, 110001, China
Local Institution - 0049

Calgary, Alberta, T2N 5G2, Canada
Local Institution - 0050

London, Ontario, N6A 5W9, Canada
Local Institution - 0052

Heidelberg, Victoria, 3084, Australia
Local Institution - 0054

Clayton, Victoria, 3168, Australia
Local Institution - 0056

Rio de Janeiro, 20211-030, Brazil
Local Institution - 0059

Fortaleza, Ceará, 60430-270, Brazil
Local Institution - 0060

Gdansk, 80-952, Poland
Local Institution - 0061

Katowice, 40-519, Poland
Local Institution - 0062

Warsaw, 02-172, Poland
Local Institution - 0069

Huixquilucan, State of Mexico, 52787, Mexico
Local Institution - 0070

Clovis, California, 93611, United States
Local Institution - 0071

Blacktown, New South Wales, 2148, Australia
Local Institution - 0075

Chengdu, Sichuan, 610041, China
Local Institution - 0076

Reggio Calabria, 89133, Italy
Local Institution - 0079

Nanchang, Jiangxi, 330006, China
Local Institution - 0080

Brno, Brno-město, 625 00, Czechia
Local Institution - 0082

Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00, Greece
Local Institution - 0083

Suzhou, Jiangsu, 215006, China
Local Institution - 0084

Athens, Attikí, 115 27, Greece
Local Institution - 0085

Turin, Piedmont, 10128, Italy
Local Institution - 0089

Changsha, Hunan, 410008, China
Local Institution - 0090

Prague, 12808, Czechia
Local Institution - 0092

Ostrava, Moravian-Silesian Region, 708 52, Czechia
Local Institution - 0101

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Local Institution - 0103

Tianjin, Tianjin Municipality, 300020, China
Local Institution - 0106

Tampa, Florida, 33612, United States
Local Institution - 0108

Wuhan, Hubei, 430058, China
Local Institution - 0109

Hefei, Anhui, 230001, China
Local Institution - 0111

Qingdao, Shandong, 266003, China
Local Institution - 0112

Vancouver, British Columbia, V6Z 1Y6, Canada
Local Institution - 0113

Camperdown, New South Wales, 2050, Australia
Local Institution - 0116

La Tronche, Isère, 38700, France
Local Institution - 0128

Hattiesburg, Mississippi, 39401, United States
Local Institution - 0130

Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland
Local Institution - 0131

Chaïdári, Attikí, 12462, Greece
Local Institution - 0132

Pátrai, Achaḯa, 26504, Greece
Local Institution - 0133

Verona, 37134, Italy
Local Institution - 0134

Milan, Milano, 20162, Italy
Local Institution - 0135

Bologna, 40138, Italy
Local Institution - 0136

Rozzano, Milano, 20089, Italy
Local Institution - 0137

Milan, Lombardy, 20122, Italy
Local Institution - 0138

Florence, Tuscany, 50134, Italy
Local Institution - 0140

Toulouse, 31100, France
Local Institution - 0142

Mexico City, 14080, Mexico
Local Institution - 0147

Medellín, Antioquia, 05034, Colombia
Local Institution - 0149

Montería, 230002, Colombia
Local Institution - 0150

Puebla City, 72424, Mexico
Local Institution - 0152

Valledupar, Cesar Department, 200001, Colombia
Local Institution - 0156

Oaxaca City, Oaxaca, 68020, Mexico
Local Institution - 0163

Plantation, Florida, 33322, United States
Local Institution - 0165

Vandœuvre-lès-Nancy, Lorraine, 54511, France
Local Institution - 0166

Würzburg, 97080, Germany
Local Institution - 0167

Mutlangen, 73557, Germany
Local Institution - 0168

Koblenz, Rhineland-Palatinate, 56068, Germany
Local Institution - 0169

Berlin, 10117, Germany
Local Institution - 0171

Leipzig, Saxony, 04103, Germany
Local Institution - 0173

New Haven, Connecticut, 06510, United States
Local Institution - 0174

Knoxville, Tennessee, 37920, United States
Local Institution - 0177

Bengaluru, Karnataka, 560027, India
Local Institution - 0178

Bhubaneswar, Odisha, 751003, India
Local Institution - 0179

Fountain Valley, California, 92708, United States
Local Institution - 0180

Jacksonville, Florida, 32207, United States
Local Institution - 0183

Walnut Creek, California, 94598, United States
Local Institution - 0184

Skokie, Illinois, 60077, United States
Local Institution - 0191

Baton Rouge, Louisiana, 70808, United States
Local Institution - 0193

New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0194

Zhengzhou, Henan, 450003, China
Local Institution - 0196

Valencia, Valenciana, Comunitat, 46010, Spain
Local Institution - 0197

L'Hospitalet de Llobregat, Catalunya [Cataluña], 08908, Spain
Local Institution - 0198

Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0199

Granada, 18012, Spain
Local Institution - 0200

Salamanca, 37007, Spain
Local Institution - 0201

St. Petersburg, Florida, 33705, United States
Local Institution - 0202

Fort Myers, Florida, 33901, United States
Local Institution - 0203

Kennewick, Washington, 99336, United States
Local Institution - 0206

Columbus, Ohio, 43210, United States
Local Institution - 0207

Düsseldorf, 40225, Germany
Local Institution - 0209

Oxnard, California, 93030, United States
Local Institution - 0211

Los Alamitos, California, 90720, United States
Local Institution - 0212

Hackensack, New Jersey, 07601, United States
Local Institution - 0216

Xi’an, Shanxi, 710068, China
Local Institution - 0217

Beijing, Beijing Municipality, 100044, China
Local Institution - 0218

Shanghai, Shanghai Municipality, 200030, China
Local Institution - 0219

San Juan, 00917, Puerto Rico
Local Institution - 0220

Xiamen, Fujian, 361003, China
Local Institution - 0222

Saint Louis Park, Minnesota, 55426, United States
Local Institution - 0223

Chongqing, Chongqing Municipality, 400016, China
Local Institution - 0224

Margate, Florida, 33063, United States
Local Institution - 0227

Hartford, Connecticut, 06102, United States
Local Institution - 0228

Houston, Texas, 77030, United States
Local Institution - 0229

Roanoke, Virginia, 24014, United States
Local Institution - 0235

New Delhi, National Capital Territory of Delhi, 110085, India
Local Institution - 0236

Richmond, Virginia, 23219, United States
Local Institution - 0238

Tamarac, Florida, 33321, United States
Local Institution - 0240

Honolulu, Hawaii, 96813, United States
Local Institution - 0243

Ahmedabad, Gujarat, 380009, India
Local Institution - 0244

Roma, 00168, Italy
Local Institution - 0245

Athens, Attikí, 11527, Greece
Local Institution - 0246

Gold Coast, Queensland, 4217, Australia
Local Institution - 0247

Orange, California, 92868, United States
Local Institution - 0248

Villejuif, Val-de-Marne, 94805, France
Local Institution - 0251

Jena, Thuringia, 07747, Germany
Local Institution - 0252

Madrid, 28006, Spain
Local Institution - 0254

Coffs Harbour, New South Wales, 2450, Australia
Local Institution - 0255

Lübeck, 23562, Germany
Local Institution - 0256

Rome, Lazio, 00133, Italy
Local Institution - 0258

Los Angeles, California, 90095, United States
Local Institution - 0259

Münster, North Rhine-Westphalia, 48153, Germany
Local Institution - 0261

Erding, Bavaria, 85435, Germany
Local Institution - 0266

Shijiazhuang, Hebei, 050000, China
Local Institution - 0267

Piedecuesta, Santander Department, 681017, Colombia
Local Institution - 0269

Angers, Maine-et-Loire, 49933, France
Local Institution - 0270

Dyer, Indiana, 46311, United States
Local Institution - 0271

Oviedo, 33011, Spain
Local Institution - 0272

Chicago, Illinois, 60611, United States
Local Institution - 0274

Seville, 41013, Spain
Local Institution - 0276

Santiago, Santiago Metropolitan, 7580206, Chile
Local Institution - 0277

Santiago, Santiago Metropolitan, 8420383, Chile
Local Institution - 0278

Santiago, Santiago Metropolitan, 7500921, Chile
Local Institution - 0280

Santiago, Santiago Metropolitan, 7500587, Chile
Local Institution - 0281

Ningbo, Zhejiang, 315010, China

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