A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study

PHASE3CompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

March 11, 2011

Primary Completion Date

March 1, 2013

Study Completion Date

August 29, 2017

Conditions
Multiple Myeloma
Interventions
DRUG

pomalidomide

4 mg pomalidomide capsules administered orally

DRUG

Dexamethasone

40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally

Trial Locations (94)

1205

Hopitaux Universitaires de Geneve-HUG, Geneva

2050

Royal Prince Alfred Hospital, Camperdown

2500

Wollongong Hospital, Wollongong

3000

UZ Leuven, Leuven

3002

Peter MacCallum Cancer Institute, East Melbourne

3004

Alfred hospital, Melbourne

3199

Frankston Hospital, Frankston

3690

Border Medical Oncology, Wodonga

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense C

6009

Sir Charles Gairdner Hospital, Nedlands

7100

Vejle Hospital, Vejle

8091

UniversitatSspital Zurich, Zurich

9000

UZ Gent, Ghent

Hæmatologisk afd. B Aalborg Sygehus Syd, Aalborg

10043

AOU San Luigi Gonzaga, Orbassano

10126

Azienda Ospedaliera San Giovanni Battista, Torino

11528

Alexandra General Hospital of Athens, Athens

13009

Institut Paoli-Calmettes, Marseille

16132

Clinica Ematologica- A.O.U. San Martino, Genova

20014

Hospital Donostia, San Sebastián (Guipuzcoa)

20099

Askepios Klinik St. Georg, Hamburg

28006

Hospital de La Princesa, Madrid

28041

Hospital 12 de Octubre, Madrid

29100

Hospital Clinic, Placenza

31059

Hopital Purpan, Tulouse Cedex 9

33604

CHRU - Hopital du Haut Leveque, Pessac

35128

Universita degli Studi di Padova, Padua

37007

Hospital Universitario de Salamanca, Salamanca

37044

Hopital Bretonneau, Tours

39008

Hospital Universitario Marques de Valdecilla, Santander

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna

42100

Servizio di Ematologia, A.O. - Arcispedale S.Maria Nuova, Reggio Emilia

44093

CHRU Nantes, Nantes

45122

Universitatsklinikum Essen, Essen

46009

Hospital de la Fe, Valencia

49033

CHU d'Angers, Angers

54511

CHU Nancy, Vandœuvre-lès-Nancy

55905

Mayo Clinic, Rochester

59037

CHRU de Lille FR, Lille

64109

Centre Hospitalier de la cote basque, Bayonne

69120

Universitatsklinikum Heidelberg, Heidelberg

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

72076

University of Tubingen, Tübingen

75185

Overlakare Medocomcentrum, hematologi, Uppsala

75475

Hopital Saint-Louis, Paris

75571

CHU Hôpital St-Antoine, Paris

80131

Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

85025

Centre Hospitalier Departemental, La Roche-sur-Yon

89081

Universitatsklinikum Ulm, Ulm

97080

Universitatsklinikum Wurzburg, Würzburg

125167

State Institution Hematological Research, Centre of Russian Academy of Medical Science, Moscow

125284

State Institution Moscow Regional Research Clinical Institute, Moscow

191024

St. Petersburg Research Institute of Hematology and Blood Transfusion, Saint Petersburg

197022

State Educational Institution, Saint Petersburg State Medical University, Saint Petersburg

QLD4102

Princess Alexandra Hospital, Brisbane

NSW 2298

Calvary Mater Hospital, Waratah

B-5530

CHU UCL Mont-Godinne-Dinant asbl, Yvoir

T2N 4N2

Tom Baker Cancer Center, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 4E6

British Columbia Cancer Agency, Vancouver

B3H 2Y9

James Cancer Hospital, Halifax

L8V 5C2

Juravinski Cancer Centre, Hamilton

N6C 6B5

London Health Sciences Centre, London

M5G 2M9

University Health Network, Toronto

H1T 2M4

Maisonneuve Rosemont, Montreal

H3A 1A1

Royal Victoria Hospital McGill Department of Oncology(RVH), Montreal

H3T 1E2

Sir Mortimer B. Davis - Jewish Genl, Montreal

128 08

Charles University General Hospital, Prague

DK-8000

Aarhus University Hospital, Arhus C

01307

Universitatsklinikum Carl Gustav Carus, Dresden

07740

Universitatsklinikum Jena, Jena

04103

Universitatsklinikum Leipzig, Leipzig

00161

Univerita La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia, Rome

1081 HV

VU University Medical Center, Amsterdam

3015 CE

Erasmus Medical Center, Rotterdam

3584 CX

University Medical Center Utrecht, Utrecht

08916

Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona)

08036

Hospital Clinic Provincial de Barcelona, Barcelona

S-413 45

Department of Hematology Hematology Centre, Gothenburg

221 85

University Hospital in Lund, Lund

SE 17176

Karolinska University Hospital Huddinge, Stockholm

SE-171 76

Karolinska University Hospital, Stockholm

CH - 3010

Medizinische Universitatsklinik, Bern

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

LS9 7TF

St James's University Hospital, Leeds

EC1A 7BE

St.Bartholomew's Hospital, London

SE5 9RS

King's College Hospital, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

NG5 1PB

Nottingham City Hospital, Nottingham

PL6 8DH

Derriford Hospital, Plymouth

S10 2JF

Royal Hallamshire HospitalSheffield Teaching Hospitals NHS Trust, Sheffield

SM2 5PT

The Royal Marsden Hospital, Sutton-Surrey

WV10 0QP

The Royal Wolverhampton Hospital NHS Trust, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY