⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: