Spots Global Cancer Trial Database for Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Official Title: A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma
Study ID: NCT01712789
Conditions
Study Description
Brief Summary: The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical University of Graz, Graz, , Austria
Medizinische Universitat Innsbruck, Innsbruck, , Austria
Wilhelminenspital Vienna, Vienna, , Austria
Medical University of Vienna, Vienna, , Austria
AZ St-Jan Brugge Oostende AV, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
VUB Vrije Universiteit Brussel, Brussel, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liege, Liege, , Belgium
CHU Mont -Godinne, Yvoir, , Belgium
Aarhus University Hospital, Aarhus, , Denmark
Odense University Hospital, Odense, , Denmark
Vejle Hospital, Vejle, , Denmark
Tartu University Hospital Clinic, Tartu, , Estonia
Helsingin yliopistollinen keskussairaala, Helsinki, , Finland
Turku University Hospital, Turku, , Finland
Centre Hospitalier de la cote basque, Bayonne, , France
Hopital Henri Mondor, Créteil, , France
Hopital A. Michallon, La Tronche, , France
CHRU Claude Huriez, Lille, , France
Institut Paoli Calmette Hematologie, Marseille cedex, , France
CHU Hotel Dieu, Nantes, , France
Hopital Saint Antoine, Paris, , France
Service Hemato-Immunologie Hopital St Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Bénite, , France
CHU de Reims, Reims cedex, , France
Hematologie - CHU Purpan, Toulouse, , France
CHRU Hopital Bretonneau, Tours cedex, , France
CHU Nancy Hematology, Vandoeuvre les Nancy, , France
Charite, Campus Benjamin Franklin Universitatsmedizin Berlin, Berlin, , Germany
Klinikum Chemnitz, Chemnitz, , Germany
Universitatsklinikum Carl Gustav Carus, Dresden, , Germany
Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie, Dusseldorf, , Germany
Universitatsklinikum Essen-, Essen, , Germany
Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik, Freiburg, , Germany
Abt Haematologie - Onkologie / Allg. Krankenhaus Altona, Hamburg, , Germany
Universitatsklinikum Heidelberg, Heidelberg, , Germany
Universitatsklinikum Jena, Jena, , Germany
University of Schleswig Holstein, Kiel, , Germany
Klinikum der Universitat zu Koln, Köln, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
Universitatsklinik MuensterMedizinische Klinik A, Muenster, , Germany
TU München - Klinikum rechts der Isar, München, , Germany
UKT Universitaetsklinikum Tuebingen, Tuebingen, , Germany
University Hospital of Ulm, Ulm, , Germany
Universitatsklinikum Wurzburg, Würzburg, , Germany
University of Athens, Athens, , Greece
Cork University HospitalHaematology Consultant, Wilton, Cork, Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
University Hospital Galway, Galway, , Ireland
Ospedali Riuniti di Ancona, Ancona, , Italy
A.O. Policlinico - Università di Bari, Bari, , Italy
University of Bologna, Bologna, , Italy
Ospedale Ferrarotto, Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, Milano, , Italy
Universita degli Studi di Padova, Padova, , Italy
Casa di Cura La Maddalena, Palermo, , Italy
Ospedale Civile di Piacenza, Piacenza, , Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, , Italy
Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I, Roma, , Italy
Ospedale Sant'Eugenio, Rome, , Italy
Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette, Torino, , Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine, Udine, , Italy
Ospedale San Bortolo, Vicenza, , Italy
VU University Medical Center VU Medisch Centrum, Amsterdam, , Netherlands
Haga Hospital, Den Haag, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Oslo University Hospital, Rikshospitalet HF, Oslo, , Norway
St. Olavs Hospital Trondheim, Trondheim, , Norway
Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii, Gdansk, , Poland
Szpitala Uniwersyteckiego w. Krakowie, Kraków, , Poland
Instytut Hematologii i Transfuzjologii w Warszawie, Warszawa, , Poland
Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra, Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa, Lisboa, , Portugal
Hospital de Santa Maria, Lisboa, , Portugal
Hospital Geral de Santo António - Serviço de Hematologia Clínica, Porto, , Portugal
University Hospital Bratislava - Hospital Ss Cyril and Methodius, Bratislava, , Slovakia
Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona), , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario de Canarias, La Laguna (Tenerife), , Spain
Hospital de La Princesa, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen De La Victoria, Malaga, , Spain
Hospital Morales Meseguer, Murcia, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital de Donosti, San Sebastián (Guipuzcoa), , Spain
Hospital Clinico Universitario De Santiago De Compostela, Santiago De Compostela, , Spain
Hospital Virgen de la Salud, Toledo, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Universitetssjukhuset i Lund, Lund, , Sweden
Karolinska University HospitalSolna, Stockholm, , Sweden
Universitatsspital Bern, Bern, , Switzerland
Hopitaux Universitaires de Geneve-HUG, Genèva, , Switzerland
University Hospital Zurich, Zurich, , Switzerland
Ankara University Medical Faculty Cebeci Hospital, Ankara, , Turkey
Ege University Medical School, Izmir, , Turkey
Belfast City Hospital Haematology Department, Belfast Northern Ireland, , United Kingdom
Kent and Canterbury Hospital, Canterbury/Kent, , United Kingdom
Leeds Teaching Hospitals Trust, Leeds, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Newcastle Hospital Foundation Trust, Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital, Sutton (Surrey), , United Kingdom
Southmead Hospital, Westbury-on-Trym/ Bristol, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
Name: Teresa Peluso, MBBS, DCPSA
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
