Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence

PHASE3CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

September 8, 2010

Primary Completion Date

January 1, 2013

Study Completion Date

May 15, 2018

Conditions
Primary MyelofibrosisMPN-associated Myelofibrosis
Interventions
DRUG

Pomalidomide 0.5 mg

Pomalidomide 0.5 mg capsule taken by mouth once daily. Immunomodulatory agent with demonstrated efficacy in the treatment of subjects with RBC-transfusion-dependence associated with MNP-associated myelofibrosis.

DRUG

Placebo

Placebo Comparator to active drug; Placebo capsule taken by mouth once daily

DRUG

Pomalidomide

Pomalidomide 0.5 mg capsule taken by mouth once daily.

Trial Locations (87)

2065

Royal North Shore Hospital, St Leonards

2250

Gosford Hospital, Gosford

3000

Universitaire Ziekenhuis Leuven Gathuisberg, Leuven

3050

Royal Melbourne Hospital, Parkville

3199

Frankston Hospital, Frankston

6000

Grand Hopital de Charleroi, Charleroi

8000

Algemeen Ziekenhuis Sint-Jan, Bruges

10021

Weill Medical College of Cornell University, New York

10029

Ruttenberg Treatment Center, New York

10043

Azienda Ospedaliera San Luigi Gonzaga, Orbassano

10065

Memorial Sloan Kettering Cancer Center, New York

11212

Mount Sinai School of Medicine Brookdale University Hospital, Brooklyn

14185

Karolinska University Hospital Huddinge, Stockholm

19107

Thomas Jefferson University, Philadelphia

21100

Ospedale di Circolo e Fondazione Macchi Varese, Varese

22185

Skane University Hospital, Lund

24128

Ospedali Riuniti di Bergamo, Bergamo

27100

IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Centro per lo Studio della Mielofibrosi, Pavia

IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Ematologia, Pavia

28222

Hospital Universitario Puerta De Hierro Majadahonda, Majadahonda

30625

Medizinische Hochschule Hannover, Hanover

31059

Hopital Purpan, Toulouse

32224

Mayo Clinic, Jacksonville

32429

Johannes Wesling Klinikum Minden, Minden

32610

University of Florida Shands Cancer Center, Gainesville

33604

CHRU - Hopital du Haut Leveque, Pessac

37007

Hospital Clinico de Salamanca, Salamanca

38043

Hopital Albert Michallon, La Tronche

44195

Medicine Taussig Cancer Institute, Cleveland

46010

Hospital Clinico de Valencia, Valencia

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

50134

Azienda Ospedaliera Universitaria Careggi, Florence

52074

Universitatsklinikum Aachen, Aachen

55905

Mayo Clinic, Rochester

57105

Avera Hematology and Transplant, Sioux Falls

59020

Hopital Saint Vincent de Paul, Lille

60612

University of Illinois at Chicago, Chicago

67098

Hopitaux Universitaires de Strasbourg, CHU Haute-Pierre, Strasbourg

70124

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari

75475

Hopital Saint-Louis, Paris

77030

MD Anderson Cancer Center, Houston

80131

Azienda Ospedaliera Universitaria Federico II di Napoli, Napoli

84132

University of Utah, Salt Lake City

85259

Mayo Clinic, Scottsdale

87042

CHU Dupuytren, Limoges

89081

Universitatsklinikum Ulm, Ulm

90095

UCLA School of Medicine, Los Angeles

94805

Institut Gustave Roussy, Villejuif

98109

Fred Hutchinson Cancer Center, Seattle

100044

Peking University People's Hospital, Beijing

100730

Peking Union Medical College Hospital, Beijing

125167

Russian Scientific Haematology Centre, Moscow

191024

Federal State Institution Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-Biological Agency of Russia, Saint Petersburg

196022

State Pavlov Medical University, Saint Petersburg

197341

"Federal State Institution Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies named after V.A. Almazov", Saint Petersburg

200025

Shanghai Ruijin Hospital, Shanghai

210029

Jiangsu Province Hospital, Jiangsu

300041

Blood Disease Hospital Chinese Academy of Medical Sciences, Tianjin

610041

West China Hospital, Sichuan University, Sichuan

A-8036

Medizinische Universitatklinik Graz, Graz

A-6020

Medizinische Universitat Innsbruck, Innsbruck

A-1190

Medizinische Universitat Wien, Vienna

T6G lz2

Cross Cancer Institute, Edmonton

V5Z 1M9

Vancouver General Hospital, Vancouver

M5G 2M9

Princess Margaret Hospital, Toronto

Unknown

Centre Hospitalier de L'Universite de Montreal, Montreal

04103

Universitatsklinikum Leipzig, Leipzig

113-8431

Juntendo University Hospital, Bunkyou-ku

812-8582

Kyushu University Hospital, Fukuoka

259-1193

Tokai University Hospital, Isehara

606-8507

Kyoto University Hospital, Kyoto

852-8501

Nagasaki University Hospital, Nagasaki

160-0023

Tokyo Medical University Hospital, Shinjuku

1081 HV

VU University Medical Center, Amsterdam

3015 CE

Erasmus Medish Centrum, Rotterdam

3584 CX

University Medical Center Utrecht, Utrecht

35-055

Wojewodzki Szpital Specjalistyczny im. F.Chopina, Rzeszów

71-242

Samodzielny Publiczny Szpital Kliniczny Nr 1 PAM, Szczecin

02-507

Centralny Szpital Kliniczny MSWiA, Warsaw

08036

Hospital Clinic I Provincial de Barcelona, Barcelona

BT9 7AB

Belfast City Hospital, Belfast

G12 0YN

Beatson Oncology Centre, Glasgow

OX3 9DU

John Radcliffe Hospital NHS Trust, Headington

SE1 9RT

St. Thomas Hospital, London

W12 ONN

Hammersmith Hospital, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

S10 2JF

Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY