Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

682

Participants

Timeline

Start Date

November 6, 2012

Primary Completion Date

December 11, 2019

Study Completion Date

December 11, 2019

Conditions
Multiple Myeloma
Interventions
DRUG

Pomalidomide

Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle

DRUG

Dexamethasone

Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.

Trial Locations (112)

1000

Institut Jules Bordet, Brussels

1090

VUB Vrije Universiteit Brussel, Brussels

1160

Wilhelminenspital Vienna, Vienna

1211

Hopitaux Universitaires de Geneve-HUG, Genèva

3000

UZ Leuven, Leuven

3010

Universitatsspital Bern, Bern

4000

Centre Hospitalier Universitaire de Liege, Liège

5530

CHU Mont -Godinne, Yvoir

6020

Medizinische Universitat Innsbruck, Innsbruck

7100

Vejle Hospital, Vejle

8000

AZ St-Jan Brugge Oostende AV, Bruges

Aarhus University Hospital, Aarhus

8091

University Hospital Zurich, Zurich

8916

Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona)

9000

UZ Gent, Ghent

10126

Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette, Torino

11528

University of Athens, Athens

12200

Charite, Campus Benjamin Franklin Universitatsmedizin Berlin, Berlin

13273

Institut Paoli Calmette Hematologie, Marseille

15706

Hospital Clinico Universitario De Santiago De Compostela, Santiago de Compostela

20014

Hospital de Donosti, San Sebastián (Guipuzcoa)

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milano, Milan

20521

Turku University Hospital, Turku

24105

University of Schleswig Holstein, Kiel

28006

Hospital de La Princesa, Madrid

28034

Hospital Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital 12 de Octubre, Madrid

29010

Hospital Universitario Virgen De La Victoria, Málaga

29100

Ospedale Civile di Piacenza, Piacenza

30008

Hospital Morales Meseguer, Murcia

31008

Clinica Universidad de Navarra, Pamplona

31059

Hematologie - CHU Purpan, Toulouse

33100

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine, Udine

35100

Ege University Medical School, Izmir

35128

Universita degli Studi di Padova, Padua

36100

Ospedale San Bortolo, Vicenza

37007

Hospital Universitario de Salamanca, Salamanca

37044

CHRU Hopital Bretonneau, Tours

38320

Hospital Universitario de Canarias, La Laguna (Tenerife)

38700

Hopital A. Michallon, La Tronche

40138

University of Bologna, Bologna

44093

CHU Hotel Dieu, Nantes

45004

Hospital Virgen de la Salud, Toledo

45122

Universitatsklinikum Essen-, Essen

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

48129

Universitatsklinik MuensterMedizinische Klinik A, Münster

50937

Klinikum der Universitat zu Koln, Cologne

51014

Tartu University Hospital Clinic, Tartu

51092

CHU de Reims, Reims

54511

CHU Nancy Hematology, Vandœuvre-lès-Nancy

56126

Azienda Ospedaliero-Universitaria Pisana, Pisa

59037

CHRU Claude Huriez, Lille

60126

Ospedali Riuniti di Ancona, Ancona

64109

Centre Hospitalier de la cote basque, Bayonne

69120

Universitatsklinikum Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

A.O. Policlinico - Università di Bari, Bari

72076

UKT Universitaetsklinikum Tuebingen, Tübingen

75012

Hopital Saint Antoine, Paris

75475

Service Hemato-Immunologie Hopital St Louis, Paris

81675

TU München - Klinikum rechts der Isar, München

85107

University Hospital Bratislava - Hospital Ss Cyril and Methodius, Bratislava

89081

University Hospital of Ulm, Ulm

90146

Casa di Cura La Maddalena, Palermo

94010

Hopital Henri Mondor, Créteil

95124

Ospedale Ferrarotto, Catania

97080

Universitatsklinikum Wurzburg, Würzburg

A-8036

Medical University of Graz, Graz

A-1090

Medical University of Vienna, Vienna

DK-5000

Odense University Hospital, Odense

FI-00290

Helsingin yliopistollinen keskussairaala, Helsinki

D-09113

Klinikum Chemnitz, Chemnitz

01307

Universitatsklinikum Carl Gustav Carus, Dresden

D-40225

Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie, Düsseldorf

D-79106

Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik, Freiburg im Breisgau

D-22763

Abt Haematologie - Onkologie / Allg. Krankenhaus Altona, Hamburg

O7740

Universitatsklinikum Jena, Jena

04103

Universitatsklinikum Leipzig, Leipzig

Unknown

Cork University HospitalHaematology Consultant, Wilton

Dublin 7

Mater Misericordiae University Hospital, Dublin

ST46QG

University Hospital Galway, Galway

00168

Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I, Roma

00144

Ospedale Sant'Eugenio, Rome

1081 HV

VU University Medical Center VU Medisch Centrum, Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

3015 CE

Erasmus Medical Center, Rotterdam

2545 CH

Haga Hospital, The Hague

3584 CX

University Medical Center Utrecht, Utrecht

0424

Oslo University Hospital, Rikshospitalet HF, Oslo

N-7006

St. Olavs Hospital Trondheim, Trondheim

80-211

Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii, Gdansk

31 501

Szpitala Uniwersyteckiego w. Krakowie, Krakow

02-776

Instytut Hematologii i Transfuzjologii w Warszawie, Warsaw

3000-075

Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra, Coimbra

1099-023

Instituto Portugues de Oncologia de Lisboa, Lisbon

1649-035

Hospital de Santa Maria, Lisbon

4099-001

Hospital Geral de Santo António - Serviço de Hematologia Clínica, Porto

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

SE-22185

Universitetssjukhuset i Lund, Lund

SE 17176

Karolinska University HospitalSolna, Stockholm

06590

Ankara University Medical Faculty Cebeci Hospital, Ankara

BT9 7AB

Belfast City Hospital Haematology Department, Belfast Northern Ireland

CT1 3NG

Kent and Canterbury Hospital, Canterbury/Kent

LS9 7TF

Leeds Teaching Hospitals Trust, Leeds

L7 8XP

Royal Liverpool University Hospital, Liverpool

M20 4BX

Christie Hospital NHS Foundation Trust, Manchester

NE7 7DN

Newcastle Hospital Foundation Trust, Newcastle upon Tyne

SM2 5PT

Royal Marsden Hospital, Sutton (Surrey)

BS10 5NB

Southmead Hospital, Westbury-on-Trym/ Bristol

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT01712789 - Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter