Spots Global Cancer Trial Database for Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence
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Trial Identification
Brief Title: Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence
Official Title: A Phase-3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy and Safety of Pomalidomide in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Red Blood Cell-Transfusion-Dependence
Study ID: NCT01178281
Study Description
Brief Summary: The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only)
Detailed Description: The multicenter global study was conducted in 15 countries including Australia, Austria, Belgium, Canada, China, France, Germany, Italy, Japan, the Netherlands, Russia, Spain, Sweden, the United Kingdom, and the United States. The global study enrolled participants with myeloproliferative neoplasm (MPN)-associated myelofibrosis and RBC-transfusion-dependence. Participants were randomly assigned to receive pomalidomide or placebo in a blinded fashion. In most countries participating in the global study, RBC-transfusions are typically given for a hemoglobin level \<80-90 g/L. In China, RBC-transfusions are rarely given unless the hemoglobin level is \<60 g/L. Consequently, few Chinese with MPN-associated myelofibrosis meet RBC-transfusion-dependence criteria of the global study. A China-specific extension was developed to test the ability of pomalidomide to improve severe anemia (defined as a hemoglobin \< 80 g/L for ≥ 84 days in persons not receiving RBC-transfusions). The China-specific extension study consisted of a single-arm, open-label study in adults with MPN-associated myelofibrosis and severe anemia not receiving RBC transfusions with the objective of describing the frequency of anemia response. The Global (intent-to-treat \[ITT\] and safety) population in the main study and the China extension (ITT and safety) population are mutually exclusive.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Scottsdale, Arizona, United States
UCLA School of Medicine, Los Angeles, California, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Mayo Clinic, Jacksonville, Florida, United States
University of Illinois at Chicago, Chicago, Illinois, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Mount Sinai School of Medicine Brookdale University Hospital, Brooklyn, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
Ruttenberg Treatment Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Medicine Taussig Cancer Institute, Cleveland, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Avera Hematology and Transplant, Sioux Falls, South Dakota, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Gosford Hospital, Gosford, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Frankston Hospital, Frankston, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Medizinische Universitatklinik Graz, Graz, , Austria
Medizinische Universitat Innsbruck, Innsbruck, , Austria
Medizinische Universitat Wien, Vienna, , Austria
Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
Universitaire Ziekenhuis Leuven Gathuisberg, Leuven, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hospitalier de L'Universite de Montreal, Montreal,, , Canada
Peking University People's Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Jiangsu Province Hospital, Jiangsu, , China
Shanghai Ruijin Hospital, Shanghai, , China
West China Hospital, Sichuan University, Sichuan, , China
Blood Disease Hospital Chinese Academy of Medical Sciences, Tianjin, , China
Hopital Albert Michallon, La Tronche, , France
Hopital Saint Vincent de Paul, Lille, , France
CHU Dupuytren, Limoges, , France
Hopital Saint-Louis, Paris, , France
CHRU - Hopital du Haut Leveque, Pessac, , France
Hopitaux Universitaires de Strasbourg, CHU Haute-Pierre, Strasbourg, , France
Hopital Purpan, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Universitatsklinikum Aachen, Aachen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, , Italy
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliera Universitaria Federico II di Napoli, Napoli, , Italy
Azienda Ospedaliera San Luigi Gonzaga, Orbassano, , Italy
IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Centro per lo Studio della Mielofibrosi, Pavia, , Italy
IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Ematologia, Pavia, , Italy
Ospedale di Circolo e Fondazione Macchi Varese, Varese, , Italy
Juntendo University Hospital, Bunkyou-ku, , Japan
Kyushu University Hospital, Fukuoka City, , Japan
Tokai University Hospital, Isehara City, , Japan
Kyoto University Hospital, Kyoto City, , Japan
Nagasaki University Hospital, Nagasaki City, , Japan
Tokyo Medical University Hospital, Shinjuku, , Japan
VU University Medical Center, Amsterdam, , Netherlands
Erasmus Medish Centrum, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Wojewodzki Szpital Specjalistyczny im. F.Chopina, Rzeszow, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 PAM, Szczecin, , Poland
Centralny Szpital Kliniczny MSWiA, Warsaw, , Poland
Russian Scientific Haematology Centre, Moscow, , Russian Federation
Federal State Institution Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-Biological Agency of Russia, Saint-Petersburg, , Russian Federation
State Pavlov Medical University, Saint-Petersburg, , Russian Federation
Federal State Institution "Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies named after V.A. Almazov", Saint-Petersburg, , Russian Federation
Hospital Clinic I Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario Puerta De Hierro Majadahonda, Majadahonda, , Spain
Hospital Clinico de Salamanca, Salamanca, , Spain
Hospital Clinico de Valencia, Valencia, , Spain
Skane University Hospital, Lund, , Sweden
Karolinska University Hospital Huddinge, Stockholm, , Sweden
Belfast City Hospital, Belfast, , United Kingdom
Beatson Oncology Centre, Glasgow, , United Kingdom
John Radcliffe Hospital NHS Trust, Headington, , United Kingdom
St. Thomas Hospital, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Contact Details
Name: Robert Peter P Gale, MD, Ph.D.
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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