ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions
Launched by BRISTOL-MYERS SQUIBB · Jul 10, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The ELEMENT-MDS clinical trial is studying how effective and safe a medication called Luspatercept is for treating anemia in adults with Myelodysplastic Syndromes (MDS) who are not receiving blood transfusions. This study will compare Luspatercept to another treatment called epoetin alfa. It is specifically looking at adults aged 65 to 74 who have been diagnosed with very low, low, or intermediate-risk MDS and are experiencing symptoms of anemia, such as fatigue or weakness.
To be eligible for this trial, participants must have a confirmed diagnosis of MDS and cannot have received blood transfusions for their condition. They should also have specific levels of anemia as defined by the study. Participants can expect to either receive Luspatercept or epoetin alfa, and they will be monitored regularly to assess how well the treatments are working and whether they have any side effects. This trial is currently recruiting participants, and it aims to provide valuable information on new treatment options for people with MDS and anemia.
Gender
ALL
Eligibility criteria
- • 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.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sioux Falls, South Dakota, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Tampa, Florida, United States
Clovis, California, United States
Cleveland, Ohio, United States
Jacksonville, Florida, United States
Toronto, Ontario, Canada
Houston, Texas, United States
Knoxville, Tennessee, United States
Hackensack, New Jersey, United States
Vancouver, British Columbia, Canada
Skokie, Illinois, United States
Calgary, Alberta, Canada
Camperdown, New South Wales, Australia
Jacksonville, Florida, United States
Coffs Harbour, New South Wales, Australia
Kennewick, Washington, United States
Oxnard, California, United States
Orange, California, United States
Madrid, , Spain
Heidelberg, Victoria, Australia
Blacktown, New South Wales, Australia
Sevilla, , Spain
New Haven, Connecticut, United States
New Delhi, Delhi, India
Paris, , France
Albuquerque, New Mexico, United States
Chongqing, Chongqing, China
Patras, , Greece
Leipzig, Sachsen, Germany
Nanjing, Jiangsu, China
Mexico City, , Mexico
Barcelona, , Spain
Fountain Valley, California, United States
Daytona Beach, Florida, United States
Valencia, , Spain
Changsha, Hunan, China
Xi'an, Shanxi, China
Changchun, Jilin, China
Jena, , Germany
Porto Alegre, Rio Grande Do Sul, Brazil
Beijing, Beijing, China
Shenyang, Liaoning, China
Budapest, , Hungary
Oviedo, , Spain
Düsseldorf, , Germany
Whittier, California, United States
Ostrava, , Czechia
Skokie, Illinois, United States
Ahmedabad, Gujarat, India
Indianapolis, Indiana, United States
Gdańsk, , Poland
Suzhou, Jiangsu, China
Roanoke, Virginia, United States
Saint Petersburg, Florida, United States
Nanchang, Jiangxi, China
Chattanooga, Tennessee, United States
Concord, California, United States
Hattiesburg, Mississippi, United States
Xiamen, Fujian, China
Athens, , Greece
Jena, Thüringen, Germany
Qingdao, Shandong, China
Clayton, Victoria, Australia
Praha 2, , Czechia
Katowice, , Poland
Athens, , Greece
Covington, Louisiana, United States
Bethesda, Maryland, United States
La Tronche, , France
San Antonio, Texas, United States
Zhengzhou, Henan, China
Milan, Milano, Italy
Fort Myers, Florida, United States
Milano, Lombardia, Italy
Firenze, Toscana, Italy
Los Alamitos, California, United States
Rozzano, Milano, Italy
Hefei, Anhui, China
Cheng Du, Sichuan, China
Alexandroupolis, , Greece
Plantation, Florida, United States
New Delhi, Delhi, India
Salamanca, , Spain
Beijing, Beijing, China
Angers, Maine Et Loire, France
Harbin, Heilongjiang, China
Mutlangen, , Germany
Chaidari, , Greece
Tamarac, Florida, United States
Hangzhou, Zhejiang, China
Nyiregyhaza, Szabolcs Szatmár Bereg, Hungary
Wałbrzych, , Poland
Chaidari, Attikí, Greece
Oaxaca, , Mexico
Hartford, Connecticut, United States
Torino, Piemonte, Italy
Pompano Beach, Florida, United States
Verona, , Italy
Brno, Brno Město, Czechia
Wuhan, Hubei, China
Patras, Achaḯa, Greece
Puebla, , Mexico
Barcelona, Barcelona [Barcelona], Spain
Tianjin, Tianjin, China
Fort Collins, Colorado, United States
Koblenz, Rheinland Pfalz, Germany
Fortaleza, Ceará, Brazil
São Paulo, , Brazil
Valencia, Valenciana, Comunitat, Spain
Villejuif, Val De Marne, France
Athens, Attikí, Greece
Ostrava, Moravskoslezský Kraj, Czechia
Xian, Shaanxi, China
Nice, Alpes Maritimes, France
La Tronche, Isère, France
Rome, Lazio, Italy
Roma, , Italy
London, Ontario, Canada
Richmond, Virginia, United States
Pessac, Aquitaine, France
L'hospitalet De Llobregat, Catalunya [Cataluña], Spain
Gold Coast, Queensland, Australia
Los Angeles, California, United States
Valledupar, Cesar, Colombia
Athens, Attikí, Greece
Shanghai, Shanghai, China
Tours, Indre Et Loire, France
Bologna, , Italy
Granada, , Spain
Baton Rouge, Louisiana, United States
Warsaw, , Poland
Shijiazhuang, Hebei, China
Santiago, Región Metropolitana De Santiago, Chile
Columbus, Ohio, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Blacktown, New South Wales, Australia
Camperdown, New South Wales, Australia
Clayton, Victoria, Australia
Heidelberg, Victoria, Australia
Fortaleza, Ceará, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Hefei, Anhui, China
Beijing, Beijing, China
Beijing, Beijing, China
Fuzhou Fujian, Fujian, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Xian, Shaanxi, China
Qingdao, Shandong, China
Shanghai, Shanghai, China
Cheng Du, Sichuan, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Medellin, Antioquia, Colombia
Valledupar, Cesar, Colombia
Montería, Córdoba, Colombia
Vandoeuvre Lès Nancy, Lorraine, France
Toulouse, , France
Koblenz, Rheinland Pfalz, Germany
Leipzig, Sachsen, Germany
Berlin, , Germany
Berlin, , Germany
Düsseldorf, , Germany
Mutlangen, , Germany
Würzburg, , Germany
Patras, Achaḯa, Greece
Athens, Attikí, Greece
Chaidari, Attikí, Greece
Alexandroupolis, , Greece
Eger, Heves, Hungary
Nyiregyhaza, Szabolcs Szatmár Bereg, Hungary
Budapest, , Hungary
New Delhi, Delhi, India
Bhubaneswar, Odisha, India
Hyderabad, , India
Milano, Lombardia, Italy
Milan, Milano, Italy
Rozzano, Milano, Italy
Firenze, Toscana, Italy
Bologna, , Italy
Reggio Calabria, , Italy
Torino, , Italy
Verona, , Italy
Mexico City, Distrito Federal, Mexico
Huixquilucan, , Mexico
Puebla, , Mexico
Wałbrzych, Dolnośląskie, Poland
Warsaw, Mazowieckie, Poland
Gdańsk, Pomorskie, Poland
Katowice, , Poland
Barcelona, Barcelona [Barcelona], Spain
L'hospitalet De Llobregat, Catalunya [Cataluña], Spain
Valencia, Valenciana, Comunitat, Spain
Granada, , Spain
Salamanca, , Spain
Xiamen, Fujian, China
Guangzhou, Guangdong, China
San Juan, , Puerto Rico
Saint Louis Park, Minnesota, United States
Chongqing, Chongqing, China
Margate, Florida, United States
Santiago, , Chile
Buenos Aires, , Argentina
Fresno, California, United States
Buenos Aires, , Argentina
Brno, Brno Město, Czechia
Ostrava, Moravskoslezský Kraj, Czechia
Praha 2, , Czechia
Bengaluru, Karnataka, India
New Delhi, , India
Reggio Calabria, , Italy
Buenos Aires, , Argentina
Gdańsk, , Poland
Wenzhou, Zhejiang, China
Santiago, Región Metropolitana De Santiago, Chile
Nyiregyhaza, Szabolcs Szatmár Bereg, Hungary
San Juan, , Puerto Rico
Piedecuesta, Santander, Colombia
Medellin, Antioquia, Colombia
Beijing, Beijing, China
Patras, Achaḯa, Greece
New Delhi, Delhi, India
Ahmedabad, Gujarat, India
Santiago, Región Metropolitana De Santiago, Chile
Orange, California, United States
Tamarac, Florida, United States
Honolulu, Hawaii, United States
Gold Coast, Queensland, Australia
Rio De Janeiro, , Brazil
Tours, Indre Et Loire, France
Kempten, Bayern, Germany
Roma, , Italy
Fresno, California, United States
Fort Collins, Colorado, United States
New Orleans, Louisiana, United States
Vancouver, British Columbia, Canada
Villejuif, Val De Marne, France
Jena, Thüringen, Germany
Berlin, , Germany
Wałbrzych, Dolnośląskie, Poland
Madrid, , Spain
Santiago, Región Metropolitana De Santiago, Chile
Coffs Harbour, New South Wales, Australia
Richmond, Virginia, United States
Lübeck, , Germany
Daytona Beach, Florida, United States
Pikeville, Kentucky, United States
Seattle, Washington, United States
Eger, Heves, Hungary
Würzburg, , Germany
Rome, Lazio, Italy
Münster, Nordrhein Westfalen, Germany
Erding, Bayern, Germany
Huixquilucan, , Mexico
Los Alamitos, California, United States
Los Angeles, California, United States
Buenos Aires, , Argentina
Montería, , Colombia
Hksar, , Hong Kong
Bhubaneswar, Odisha, India
Reggio Calabria, , Italy
Kitakyushu Shi, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Amagasaki, Hyogo, Japan
Sagamihara, Kanagawa, Japan
Sendai Shi, Miyagi, Japan
Osaka Sayama, Osaka, Japan
Shimotsuga, Tochigi, Japan
Nagasaki, , Japan
Osaka, , Japan
Tokyo, , Japan
Mexico City, , Mexico
Shijiazhuang, Hebei, China
Suzhou, Jiangsu, China
Oviedo, , Spain
Angers, Maine Et Loire, France
Athens, Attikí, Greece
Sevilla, , Spain
Dyer, Indiana, United States
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Ciudad Autónoma De Buenos Aires, , Argentina
Ahmedabad, Gujarat, India
Piedecuesta, Santander, Colombia
Chicago, Illinois, United States
Calgary, Alberta, Canada
Santiago, Región Metropolitana De Santiago, Chile
Calgary, Alberta, Canada
Münster, Nordrhein Westfalen, Germany
Erding, Bayern, Germany
Roma, , Italy
Dyer, Indiana, United States
Fortaleza, , Brazil
Tampa, Florida, United States
Montería, , Colombia
Roma, , Italy
Würzburg, , Germany
Ningbo, Zhejiang, China
Brno, , Czechia
L'hospitalet De Llobregat, , Spain
Nyiregyhaza, , Hungary
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Patras, , Greece
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported