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Spots Global Cancer Trial Database for Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

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Trial Identification

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

Study Description

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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