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Brief Title: Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
Official Title: A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
Study ID: NCT01080391
Brief Summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.
Detailed Description: This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for adults with relapsed multiple myeloma. Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd. Randomization will be stratified by β2 microglobulin levels (\< vs ≥ 2.5 mg/L), prior bortezomib (no vs yes), and prior lenalidomide (no vs yes). Participants will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Scottsdale, Arizona, United States
Providence St. Joseph Medical Center, Burbank, California, United States
St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare, Santa Rosa, California, United States
Stanford University, Stanford, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Cancer and Blood Disease Center, Lecanto, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
The University of Michigan - Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
NYU Clinical Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Associates in Oncology and Hematology, Chattanooga, Tennessee, United States
The Don & Sybil Harrington Cancer Center, Amarillo, Texas, United States
Baylor Sammons Cancer Center, Dallas, Texas, United States
UT Southwestern Medical Center at Dallas, Dallas, Texas, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Froedtert & Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Medizinische Universitat Wien, Wien, , Austria
Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie, Wien, , Austria
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg, Antwerpen, , Belgium
AZ Sint-Jan AV, Brugge, , Belgium
UZ Brussel, Brussels, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski", Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, , Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, , Bulgaria
Tom Baker Cancer Centre, Calgary, Alberta, Canada
University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
General Hospital, Health Sciences Centre, St John's, Newfoundland and Labrador, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Health Center, Royal Victoria Hospital, Montreal, Quebec, Canada
Sir Mortimer B. Davis - Jewish General Hospital, Montreal, Quebec, Canada
University Hospital Brno, Department of Internal Medicine - Hematooncology, Brno, , Czechia
University Hospital Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
University Hospital Kralovske Vinohrady - Prague, Praha 10, , Czechia
General University Hospital Prague, Praha 2, , Czechia
Hospital Antoine Beclere, Clamart, , France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans, , France
Hopital Claude Huriez, Lille, , France
CH de Mulhouse, Hopital Emile Muller, Mulhouse, , France
CHU Nantes Hotel Dieu, Nantes, , France
Hopital Saint-Antoine, Paris, , France
Groupe Hospitalier Necker - Enfants Malades, Paris, , France
Cancer Institut Universitaire de Toulouse-Oncopole (iUCT), Toulouse, , France
Hopitaux de Brabois, Vandoeuvre-Les-Nancy, , France
University of Dusseldorf, Dusseldorf, , Germany
Krankenhaus Nordwest, Frankfurt am Main, , Germany
University of Hamburg-Eppendorf, Hamburg, , Germany
Universitat Heidelberg, Heidelberg, , Germany
Stiftungsklinikum Mittelrhein, Koblenz, , Germany
LMU Klinikum der Universitat, Munchen, , Germany
Universitatsklinikum Munster, Munster, , Germany
Universitatsklinikum Wurzburg, Wurzburg, , Germany
Alexandra Hospital, Athens, , Greece
University General Hospital of Patras, Patras, , Greece
St. Istvan and St. Laszlo Hospital of Budapest, Budapest, , Hungary
University of Debrecen, Medical and Health Science Center, Debrecen, , Hungary
Petz Aladar County Teaching Hospital, Gyor, , Hungary
Bekes County Pandy Kalman Hospital, Gyula, , Hungary
Kaposi Mor County Teaching Hospital, Kaposvar, , Hungary
University of Pecs, Pecs, , Hungary
University of Szeged, Albert Szent-Gyorgi Clinical Center, Szeged, , Hungary
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center, Ein Kerem, Jerusalem, , Israel
Western Gailee Hospital - Nahariya, Nahariya, , Israel
Rabin Medical Center, Petach Tikva, , Israel
The Chaim Sheba Medical Center, Ramat Gan, , Israel
Kaplan Medical Center, Rehovot, , Israel
Azienda Ospedallera Niguarda Ca Granda, Milano, , Italy
Azienda Ospedllero Maggiore della Carita, Novara, , Italy
Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main, Pisa, , Italy
Ospedale S. Eugenio, Roma, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, , Italy
Erasmus MC, Department of Haematology, Rotterdam, , Netherlands
University Clinical Centre, Department of Hematologii Transplantologii, Gdansk, , Poland
Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp., Gorzow Wielkopolski, , Poland
Independent Public Teaching Hospital of Medical University of Silesia in Katowice, Katowice, , Poland
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Lodz, , Poland
Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach, Suwalki, , Poland
Nicolaus Copernicus Municipal Specialist Hospital, Torun, , Poland
Maria Sklodowska-Curie Institute of Oncology, Warszawa, , Poland
Zamojski Non-Public Hospital, Zamosc, , Poland
Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation, Bucharest, , Romania
Coltea Clinical Hospital, Bucharest, , Romania
Bucharest University Emergency Hospital, Bucharest, , Romania
Regional Institute of Iasi, Iasi, , Romania
State Medical Institution Komi Republican Oncological Center, Syktyvkar, Komi Republic, Russian Federation
First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia, Izhevsk, , Russian Federation
Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center, Moscow, , Russian Federation
Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin, Moscow, , Russian Federation
Federal State Budget Institution: Hematology Research Center under MoH, Moscow, , Russian Federation
FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B, St. Petersburg, , Russian Federation
State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov, St. Petersburg, , Russian Federation
SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant, St. Petersburg, , Russian Federation
Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare, St. Petersburg, , Russian Federation
Clinical Center of Serbia, Clinic of Hematology, Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa, Belgrade, , Serbia
Military Medical Academy, Clinic of Hematology, Belgrade, , Serbia
Clinical Center Nis, Clinic of Hematology, Nis, , Serbia
Clinical Center of Vojvodina, Clinic of Hematology, Novi Sad, , Serbia
Hospital Universitario Germans Trias i Pujol, Badalona, , Spain
Hospital Clinic I Provincial, Barcelona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Donostia, San Sebastian, , Spain
Hospital Universitario y Politeecnico La Fe, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Sahlgrenska Universitetssjukhuset, Goteborg, , Sweden
Karolinska Universitetsjukhuset i Huddinge, Stockholm, , Sweden
Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum, Stockholm, , Sweden
St. Bartholomew's Hospital, London, , United Kingdom
Royal Free Hampstead, London, , United Kingdom
St. Georges Hospital, London, , United Kingdom
Nottingham University Hospitals (City Campus), Nottingham, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
The Royal Wolverhampton Hospital NHS Trust, Wolverhampton, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR