A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

January 1, 2003

Primary Completion Date

November 1, 2005

Study Completion Date

November 12, 2013

Conditions
Multiple Myeloma
Interventions
DRUG

CC-5013 plus dexamethasone

25 mg daily for 21 days every 28 days.

DRUG

Dexamethasone plus Placebo

Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.

Trial Locations (69)

1011

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

1160

Wilhelminenspital, Vienna

1200

CHU Saint-Luc, Brussels

2050

Royal Prince Alfred Hospital, Camperdown

3000

UZ Gasthuisberg, Leuven

3006

Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology, East Melbourne

3050

The Royal Melbourne Hospital, Parkville

3121

The Alfred Hospital, Prahran

3690

Border Medical Oncology, Wodonga

8091

Universitätsspital Zürich, Zurich

10003

Zhitomir Regional Clinical Hospital, Zhytomyr

10126

Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista, Torio

11538

"Alexandras General Hospital of Athens", Athens

13125

Universitaetsklinikum Charite, Berlin

13353

Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin, Berlin

16132

Azienda Ospedaliera San Martino, Genova

18009

Cherkassy Regional Oncology Center, Cherkassy

20162

Ospedale Niguarda Ca Granda, Milan

27100

Policlinico San Matteo, Pavia

28006

Hospital Universitario de la Princessa, Madrid

28041

Hospital Doce de Octubre, Madrid

31080

Clinica Universitaria de Navarra, Pamplona

31096

Rambam Medical Center, Haifa

33100

Policlinico Universitario a Gesttione diretta di Udine, Udine

33640

Chu de Bordeaux Groupe Hospitalier Sud, Pessac

37007

Hospital Universitario de Salamanca, Salamanca

39008

Hospital Universtario Marques de Valdecilla, Santander

40138

Policlinico Sant'Orsola-Malpighi, Bologna

40225

Universitaetsklinikum Dusseldorf Klinik fuer Haematologie, Düsseldorf

48129

Universitatsklinik Muenster Medizinische Klinik A, Münster

49044

Dnepropetrovsk City Clinical Hospital #4, Dnipro

52621

The Chaim Sheba Medical Center, Tel Litwinsky

54511

CHU Nancy - Hopital Brabois, Vandœuvre-lès-Nancy

59037

Hopital Claude Huriez, Lille

60590

Klininkum der Johann-Wolfgang-Goethe-Universtat, Frankfurt am Main

64239

Tel Aviv Sourasky Medical Center Department of Hematology, Tel Aviv

65025

Odess Regional Clinical Hospital, Odesa

69120

Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V, Heidelberg

72076

Universitaetsklinikum Tuebingen, Tübingen

75010

Hopital Saint-Loius, Paris

79044

Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department, Lviv

Institute of Blood Pathology and Transfusion Medicine of the UAMS, Lviv

80336

Klinikum der Univeristact Muenchen, München

91054

Universitaetsklinkum Erlangen, Erlangen

VIC 3128

Box Hill Hospital, Box Hill

VIC 3199

Frankston Hospital Oncology Research, Frankston

QLD4029

Royal Brisbane Hospital, Herston

QLD 4101

Mater Public Hospital, South Brisbane

A -5020

University Hospital of Salzburg St Johanns Spital, Salzburg

69495 Pierre Benite cedex

Centre Hospitalier Lyon Sud, Chemin Grand Revoyet

Unknown

Centre Hospitalier Hotel-Dieu, Nantes

University Hospital GalwayHaematology Department, Galway

Hope Directorate Haematology Oncology Service St. James Hospital, Dublin

MidWestern Regional Hospital, Limerick

Hadassah University Hospital, Jerusalem

Kantonsspital St. Gallen, Sankt Gallen

TSA 40031-31059

CHU Purpan, Toulouse

BT9 7AB

Belfast City HospitalHaematology Department, Belfast

00161

Univerita La Sapien, Roma

80-211

Institute of Internal Diseases University of Medicine, Gdansk

20-290

University School of Medicine, Lublin

00-957

Institute of Haematology and Blood Transfusion, Warsaw

08036

Hospital Clinic, Barcelona

S-413 45

Sahlgrenska University Hospital Department of Hematology and Coagulation, Gothenburg

03115

Kiev Bone Marrow Transplantation Center Bone Marrow Department, Kiev

04060

Institute of Hematology and Transfusiology of the UAMS Department of blood diseases, Kiev

WC1E 6AU

University College Hospital Trust, London

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

SE1 9RT

Haematology Dept, 4th Floor Thomas Guy House, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY