Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 3, Muticenter, 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 or Relapsed and Refractory Multiple Myeloma
Study ID: NCT01311687
Conditions
Study Description
Brief Summary: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Rochester, Minnesota, United States
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
Princess Alexandra Hospital, Brisbane, , Australia
Royal Prince Alfred Hospital, Camperdown, , Australia
Alfred hospital, Melbourne, , Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
Calvary Mater Hospital, Waratah, , Australia
Border Medical Oncology, Wodonga, , Australia
Wollongong Hospital, Wollongong, , Australia
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
CHU UCL Mont-Godinne-Dinant asbl, Yvoir, , Belgium
Tom Baker Cancer Center, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
James Cancer Hospital, Halifax, Nova Scotia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Maisonneuve Rosemont, Montreal, Quebec, Canada
Royal Victoria Hospital McGill Department of Oncology(RVH), Montreal, Quebec, Canada
Sir Mortimer B. Davis - Jewish Genl, Montreal, Quebec, Canada
Charles University General Hospital, Praha 2, , Czechia
Hæmatologisk afd. B Aalborg Sygehus Syd, Aalborg, , Denmark
Aarhus University Hospital, Arhus C, , Denmark
Odense Universitetshospital, Odense C, , Denmark
Vejle Hospital, Vejle, , Denmark
CHU d'Angers, Angers Cedex 01, , France
Centre Hospitalier de la cote basque, Bayonne, , France
Centre Hospitalier Departemental, La Roche sur Yon, , France
CHRU de Lille FR, Lille, , France
Institut Paoli-Calmettes, Marseille Cedex 9, , France
CHRU Nantes, Nantes Cedex 1, , France
Hopital Saint-Louis, Paris, Cedex 10, , France
CHU Hôpital St-Antoine, Paris, , France
CHRU - Hopital du Haut Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Bénite, , France
Hopital Bretonneau, Tours, , France
Hopital Purpan, Tulouse Cedex 9, , France
CHU Nancy, Vandoeuvre, , France
Universitatsklinikum Carl Gustav Carus, Dresden, , Germany
Universitatsklinikum Essen, Essen, , Germany
Askepios Klinik St. Georg, Hamburg, , Germany
Universitatsklinikum Heidelberg, Heidelberg, , Germany
Universitatsklinikum Jena, Jena, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
University of Tubingen, Tübingen, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Universitatsklinikum Wurzburg, Wuerzburg, , Germany
Alexandra General Hospital of Athens, Athens, , Greece
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy
Clinica Ematologica- A.O.U. San Martino, Genova, , Italy
Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, , Italy
AOU San Luigi Gonzaga, Orbassano, , Italy
Universita degli Studi di Padova, Padova, , Italy
Hospital Clinic, Placenza, , Italy
Servizio di Ematologia, A.O. - Arcispedale S.Maria Nuova, Reggio Emilia, , Italy
Univerita La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia, Rome, , Italy
Azienda Ospedaliera San Giovanni Battista, Torino, , Italy
VU University Medical Center, Amsterdam, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
State Institution Hematological Research, Centre of Russian Academy of Medical Science, Moscow, , Russian Federation
State Institution Moscow Regional Research Clinical Institute, Moscow, , Russian Federation
State Educational Institution, Saint Petersburg State Medical University, Saint Petersburg, , Russian Federation
St. Petersburg Research Institute of Hematology and Blood Transfusion, St. Petersburg, , Russian Federation
Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona), , Spain
Hospital Clinic Provincial de Barcelona, Barcelona, , Spain
Hospital de La Princesa, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Donostia, San Sebastián (Guipuzcoa), , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital de la Fe, Valencia, , Spain
Department of Hematology Hematology Centre, Göteborg, , Sweden
University Hospital in Lund, Lund, , Sweden
Karolinska University Hospital Huddinge, Stockholm, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Overlakare Medocomcentrum, hematologi, Uppsala, , Sweden
Medizinische Universitatsklinik, Berne, , Switzerland
Hopitaux Universitaires de Geneve-HUG, Geneva, , Switzerland
UniversitatSspital Zurich, Zürich, , Switzerland
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
St.Bartholomew's Hospital, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Freeman Hospital, Newcastle Upon Tyne, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Royal Hallamshire HospitalSheffield Teaching Hospitals NHS Trust, Sheffield, , United Kingdom
The Royal Marsden Hospital, Sutton-Surrey, , United Kingdom
The Royal Wolverhampton Hospital NHS Trust, Wolverhampton, , United Kingdom
Contact Details
Name: Lars Sternas, MD, PhD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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