The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
Launched by CELGENE · Mar 28, 2012
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 18 years or older
- • Have a documented diagnosis of MDS
- • Anemia that requires red blood cell transfusions
- • Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization
- • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- • Must agree to follow pregnancy precautions as required by protocol.
- • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
- Exclusion Criteria:
- • Secondary or hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy
- • Prior treatment with azacitidine, decitabine, other hypomethylating agents and lenalidomide (for lenalidomide : unless the last dose received is \>= 8 weeks prior to inclusion into the study).
- • Prior allogeneic or autologous stem cell transplant
- • Eligible for allogenic or autologous stem cell transplant
- • History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect
- • Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s), or microvascular disorder(s)
- • Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomization
- • Ongoing medically significant adverse events from previous treatment, regardless of the time period
- • Concurrent use of iron-chelating agents, (except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid (except for subjects on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS)
- • Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 3 years. (Basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and incidental histologic finding of prostate cancer) (T1a or T1b using the tumor, nodes, metastasis \[TNM\] clinical staging system is allowed)
- • Significant active cardiac disease within the previous 6 months
- • Uncontrolled systemic fungal, bacterial, or viral infection
- • Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection
- • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
- • Abnormal coagulation parameters
- • Abnormal liver function test results
- • Abnormal kidney function test results
- • Known or suspected hypersensitivity to azacitidine or mannitol
- • Any significant medical condition, laboratory abnormality, or psychiatric illness
About Celgene
Celgene, now a part of Bristol Myers Squibb, is a global biopharmaceutical company dedicated to advancing innovative therapies for patients with cancer and other serious diseases. With a strong emphasis on research and development, Celgene focuses on discovering and delivering transformative medicines that address unmet medical needs. The company is committed to enhancing patient outcomes through rigorous clinical trials, cutting-edge science, and collaboration with healthcare professionals, ultimately striving to improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Philadelphia, Pennsylvania, United States
Haifa, , Israel
Chicago, Illinois, United States
Rotterdam, , Netherlands
Montreal, Quebec, Canada
Hamburg, , Germany
Madrid, , Spain
Madrid, , Spain
Pittsburgh, Pennsylvania, United States
Berkeley, California, United States
Malaga, , Spain
Oviedo, , Spain
Vancouver, British Columbia, Canada
Columbus, Ohio, United States
Garran, Australian Capital Territory, Australia
Frankston, Victoria, Australia
Tel Aviv, , Israel
Seoul, , Korea, Republic Of
Chicago, Illinois, United States
Tel Hashomer, , Israel
Woolloongabba, , Australia
Toronto, Ontario, Canada
Kansas City, Missouri, United States
Barcelona, , Spain
Dresden, , Germany
Jackson, Mississippi, United States
Salamanca, , Spain
Seattle, Washington, United States
Aarhus, , Denmark
Aberdeen, , United Kingdom
Oxford, , United Kingdom
Petach Tikva, , Israel
Kansas City, Kansas, United States
Curitiba, , Brazil
Hamilton, Ontario, Canada
Clayton, Victoria, Australia
Leipzig, , Germany
Birmingham, , United Kingdom
Groningen, , Netherlands
Amsterdam, , Netherlands
Leicester, , United Kingdom
Manchester, , United Kingdom
Nijmegen, , Netherlands
Wolverhampton, , United Kingdom
Leuven, , Belgium
Ulm, , Germany
Metairie, Louisiana, United States
Bristol, , United Kingdom
Daegu, , Korea, Republic Of
Roskilde, , Denmark
Porto Alegre, Rio Grande Do Sul, Brazil
Brugge, , Belgium
Maywood, Illinois, United States
Nantes, , France
Tours, , France
Seoul, , Korea, Republic Of
Toronto, Ontario, Canada
Pavia, , Italy
Turku, , Finland
Cambridge, , United Kingdom
Kansas City, Missouri, United States
Lodz, , Poland
Gdansk, , Poland
New Haven, Connecticut, United States
Charlotte, North Carolina, United States
Roma, , Italy
Portland, Oregon, United States
Malvern, , Australia
Rennes Cedex, , France
Rouen Cedex, , France
Busan, , Korea, Republic Of
Lisboa, , Portugal
Badalona (Barcelona), , Spain
Cardiff, , United Kingdom
London, , United Kingdom
Dresden, , Germany
München, , Germany
Torrette Di Ancona, , Italy
London, , United Kingdom
Bologna, , Italy
Brno, , Czechia
Roma, , Italy
Tlalpan, , Mexico
Pierre Bénite Cedex, , France
Patras, , Greece
Pisa, , Italy
Reggio Calabria, , Italy
Krakow, , Poland
Barcelona, , Spain
Alexandroupolis, , Greece
Escondido, California, United States
Adelaide, South Australia, Australia
Strasbourg, , France
Bari, , Italy
Charleroi, , Belgium
Montreal, Quebec, Canada
Praha, , Czechia
Lille, , France
Duesseldorf, , Germany
Udine, , Italy
New Haven, Connecticut, United States
Houston, Texas, United States
Kogarah, , Australia
La Jolla, California, United States
Fitzroy, , Australia
Roma, , Italy
Torino, , Italy
Omaha, Nebraska, United States
Beverly Hills, California, United States
Duarte, California, United States
Greenbrae, California, United States
Los Angeles, California, United States
Orlando, Florida, United States
Albany, Georgia, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Worcester, Massachusetts, United States
New York, New York, United States
New York, New York, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Fort Sam Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Waukesha, Wisconsin, United States
Camperdown, , Australia
Epping, Vic, , Australia
Malvern, , Australia
Milton, Brisbane, , Australia
Waratah, , Australia
Brasschaat, , Belgium
Fortaleza, Ceará, Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Edmonton, Alberta, Canada
Barrie, Ontario, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Hradec Králové, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Praha, , Czechia
Odense C, , Denmark
Helsinki, , Finland
Lille, , France
Marseille Cedex 9, , France
Paris, , France
Paris, , France
Toulouse Cedex 9, , France
Toulouse Cedex 9, , France
Dresden, , Germany
Duesseldorf, , Germany
Dusseldorf, , Germany
Keil, , Germany
Tubingen, , Germany
Athens, , Greece
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Alessandria, , Italy
Cagliari, , Italy
Firenze, , Italy
Lecce, , Italy
Lecce, , Italy
Milano, , Italy
Milano, , Italy
Milan, , Italy
Novara, , Italy
Palermo, , Italy
Pavia, , Italy
Reggio Calabria, , Italy
Rionero In Vulture, , Italy
Terni, , Italy
Venezia Mestre, , Italy
Seoul, , Korea, Republic Of
Huixquilucan De Degollado, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Førde, , Norway
Oslo, , Norway
Bydgoszcz, , Poland
Torun, , Poland
Torun, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Beja, , Portugal
Coimbra, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Granada, , Spain
Madrid, , Spain
Seville, , Spain
Vitoria Gasteiz, álava, , Spain
Goeteborg, , Sweden
Lund, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Adana, , Turkey
Antalya, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Mersin, , Turkey
Trabzon, , Turkey
Oxford, Oxfordshire, United Kingdom
Harrow Middlesex, , United Kingdom
Hull, , United Kingdom
Liverpool, , United Kingdom
Nottingham, , United Kingdom
Sutton In Ashfield, , United Kingdom
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Praha, , Czechia
Leipzig, , Germany
Seoul, , Korea, Republic Of
Goeteborg, , Sweden
Roma, , Italy
Richmond, Virginia, United States
Houston, Texas, United States
Seattle, Washington, United States
Garran, Australian Capital Territory, Australia
Adelaide, South Australia, Australia
Clayton, Victoria, Australia
Frankston, Victoria, Australia
Camperdown, , Australia
Epping, Vic, , Australia
Fitzroy, , Australia
Kogarah, , Australia
Milton, Brisbane, , Australia
Waratah, , Australia
Woolloongabba, , Australia
Brasschaat, , Belgium
Brugge, , Belgium
Charleroi, , Belgium
Leuven, , Belgium
Fortaleza, Ceará, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Barrie, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Brno, Jihomoravský Kraj, Czechia
Olomouc, , Czechia
Praha, , Czechia
Aarhus, , Denmark
Odense C, , Denmark
Roskilde, , Denmark
Helsinki, , Finland
Turku, , Finland
Marseille Cedex 9, , France
Nantes, , France
Pierre Bénite Cedex, , France
Rennes Cedex, , France
Rouen Cedex, , France
Strasbourg, , France
Tours, , France
Dresden, , Germany
Dusseldorf, , Germany
Hamburg, , Germany
Keil, , Germany
München, , Germany
Tubingen, , Germany
Ulm, , Germany
Heraklion, Irakleio, Greece
Alexandroupolis, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Patras, , Greece
Haifa, , Israel
Petach Tikva, , Israel
Tel Hashomer, , Israel
Tel Aviv, , Israel
Alessandria, , Italy
Bari, , Italy
Bologna, , Italy
Cagliari, , Italy
Firenze, , Italy
Milan, , Italy
Novara, , Italy
Palermo, , Italy
Pisa, , Italy
Rionero In Vulture, , Italy
Roma, , Italy
Roma, , Italy
Terni, , Italy
Torino, , Italy
Torrette Di Ancona, , Italy
Udine, , Italy
Venezia Mestre, , Italy
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Huixquilucan De Degollado, , Mexico
Monterrey, , Mexico
Tlalpan, , Mexico
Amsterdam, , Netherlands
Groningen, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Førde, , Norway
Oslo, , Norway
Bydgoszcz, , Poland
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Beja, , Portugal
Coimbra, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Badalona (Barcelona), , Spain
Barcelona, , Spain
Barcelona, , Spain
Granada, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Malaga, , Spain
Oviedo, , Spain
Salamanca, , Spain
Seville, , Spain
Vitoria Gasteiz, álava, , Spain
Stockholm, , Sweden
Adana, , Turkey
Antalya, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Mersin, , Turkey
Trabzon, , Turkey
Aberdeen, , United Kingdom
Birmingham, , United Kingdom
Bristol, , United Kingdom
Cambridge, , United Kingdom
Cardiff, , United Kingdom
Harrow Middlesex, , United Kingdom
Hull, , United Kingdom
Leicester, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Sutton In Ashfield, , United Kingdom
Wolverhampton, , United Kingdom
Seattle, Washington, United States
Tel Aviv, Tel Aviv, Israel
New Haven, Connecticut, United States
Portland, Oregon, United States
Houston, Texas, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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