Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality

PHASE3CompletedINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2010

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Lenalidomide 5 mg

Lenalidomide 5 mg daily 28/28 days

DRUG

Lenalidomide 10 mg

Lenalidomide 10 mg daily 21/28 days

DRUG

Placebo

Placebo, matching to active study drug arms

Trial Locations (38)

900

UZ Gent, Ghent

3000

UZ Gasthuisberg, Leuven

5530

CHU Mont Godine, Yvoir

8000

AZ St-Jan Brugge AV, Bruges

14186

Korolinska Institutet Department of Hematology, Stockholm

20162

Ospedale Niguarda Ca Granda, Milan

27100

University of Pavia Division of Hematology, Pavia

31059

CHU Purpan, Place du Dr Baylac, Pavillon des Médecines, Toulouse

CHU Purpan, Place du Dr. Baylac, Pavillion des Medecines, Toulouse

37007

Hospital Universitario de Salamanca, Salamanca

44093

CHU Nantes Hematologie et Medicine interne, Nantes

46009

Hospital Universitario La Fe, Valencia

47166

St Johannes Hospital, Duisburg

49933

CHU d'Angers Service des Maladies du Sang, Angers

54511

CHU Nancy Hematologie et Medecine interne, Vandœuvre-lès-Nancy

59037

CHRU Lille Service des Maladies du Sang, Lille

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

75014

Hôpital Cochin Hematologie Clinique, Paris

76038

Centre Henri Becquerel Service d'Hematologie Clinique, Rouen

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

86021

Centre Jean Bernhard Service Onco-Hematologie, Poitiers

B.P.156 - 13272

Institut Paoli-Calmettes, Marseille

Unknown

Hopital Avicenne, Bobigny

06202

CHU Archet 1Hematologie Clinique, Nice

01307

Universitaetsklinikum Carl Gustav Carus, Dresden

D-30625

Hannover Medical School, Hanover

6526 GA

University of Medical Centre, Nijmegen

3000CA

Hematologie Erasmus MC, Rotterdam

SE 413 45

SU/Sahlgrenska Section of Hematology & Coagulation, Gothenburg

S-221 85

Department of Medicine University Hospital, Lund

CF14 4XW

University Hospital of Wales, Dept of Haematology, Cardiff

LS1 3 EX

Leed General Infirmary, Leeds

BH7 7DW

The Royal Bournemouth Hospital, Bournemouth

DD1 9SY

Ninewells Hospital and Medical School, Dundee

SE 5 9RS

Kings College Hospital, Denmark Hill, London

M13 9WL

Central Manchester and Manchester Children's University Hospitals NHS Trust, Manchester

NG5 1PB

Nottingham City Hospital, Nottingham

OX3 9DS

John Radcliffe Hospital and the Weatherall Institute of Molecular Medicine, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ICON Clinical Research

INDUSTRY

lead

Celgene Corporation

INDUSTRY