Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

929

Participants

Timeline

Start Date

June 20, 2012

Primary Completion Date

November 10, 2014

Study Completion Date

February 5, 2018

Conditions
Multiple Myeloma
Interventions
DRUG

Carfilzomib

Carfilzomib is administered over 30 minutes as an infusion.

DRUG

Bortezomib

Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)

DRUG

Dexamethasone

Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.

Trial Locations (241)

Unknown

Providence St. Joseph Medical Center, Burbank

UCSD Moore Cancer Center, La Jolla

UCLA Medical Center, Los Angeles

Central Coast Medical Oncology Group, Santa Maria

Colorado Blood Cancer Institute, Denver

MAB Oncology/Hematology, Melbourne

Palm Beach Cancer Institute, West Palm Beach

Winship Cancer Institute, Atlanta

Hematology Oncology of Indiana, PC, Indianapolis

Center for Cancer and Blood Disorders, Bethesda

Associates in Oncology/Hematology PC, Rockville

University of Michigan, Ann Arbor

University of Kansas, Kansas City

Hackensack University Medical Ctr, Hackensack

Clinical Research Alliance Inc., New York

Weill Cornell Medical College, New York

Montefiore Medical Center, The Bronx

Wake Forest University Health Sciences, Section on Hematology and Oncology, Winston-Salem

Gabrail Cancer Center, Canton

The Christ Hospital, Cincinnati

Western Pennsylvania Hospital, Pittsburgh

Hematology/Oncology Associates of SC, Greenville

Vanderbilt Ingram Cancer Center, Nashville

MD Anderson, Houston

The Methodist Cancer Center, Houston

Scott & White Memorial Hospital, Temple

University of Utah School of Medicine, Salt Lake City

Royal Prince Alfred Hospital, Camperdown

St. Vincent's Public Hospital Sydney, Darlinghurst

Saint George Hospital, Kogarah

Liverpool Hospital, Liverpool

Royal North Shore Hospital, Saint Leonards

Calvary Mater Newcastle, Waratah

Westmead Hospital, Westmead

Royal Brisbane and Women's Hospital, Herston

Haematology & Oncology Clinics of Australia, South Brisbane

Haematology and Oncology Clinics of Australia at Chermside, South Brisbane

Haematology and Oncology Clinics of Australia at Wesley, South Brisbane

Royal Adelaide Hospital, Adelaide

The Queen Elizabeth Hospital, Woodville

Box Hill Hospital, Box Hill

Monash Medical Centre, Clayton

Saint Vincent's Hospital, East Melbourne

Western Hospital, Footscray

The Alfred Hospital, Melbourne

Sunshine Hospital, St Albans

Fremantle Hospital, Fremantle

Royal Perth Hospital, Perth

Medizinische Universität Innsbruck, Innsbruck

Krankenhaus der Elisabethinen Linz, I Interne Abteilung, Linz

Wilhelminenspital der Stadt Wien, Vienna

Universitair Ziekenhuis Leuven, Leuven

Cliniques Universitaires UCL de Mont-Godinne, Yvoir

Universitair Ziekenhuis Gent, Ghent

Ziekenhuis Netwerk Antwerpen, Antwerp

Cliniques Universitaires Saint Luc, Brussels

Universitair Ziekenhuis Brussel, Brussels

Liga Norte Riograndense Contra o Câncer, Natal

Clínica de Oncologia de Porto Alegre, Porto Alegre

Hospital de Clínicas de Porto Alegre, Porto Alegre

Hospital São Lucas da PUCRS, Porto Alegre

Hemocentro Campinas-Unicamp, Campinas

Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro, Rio de Janeiro

Instituto Centros Oncológicos Integrados de Educação e Pesquisa, Rio de Janeiro

Instituto Nacional do Câncer-INCA, Rio de Janeiro

Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo

Military Medical Academy Hospital for Active Treatment, Sofia

Shato, Ead, Sofia

"University Multiprofile Hospital for Active Treatment Sveti Georgi EAD", Plovdiv

"Multiprofile Hospital for Active Treatment, Sveta Marina''", Varna

University of Alberta Hospital, Edmonton

British Columbia Cancer Agency, Kelowna

Saint John Regional Hospital, Saint John

Queen Elizabeth II Health Science Centre, Halifax

London Health Sciences Centre, London

The Ottawa Hospital Regional Cancer Centre, Ottawa

Windsor Regional Hospital, Windsor

Hopital Maisonneuve-Rosemont, Montreal

Fakultní nemocnice Královské Vinohrady, Prague

Fakultní nemocnice Olomouc, Olomouc

FN Ostrava, Ostrava

Fakultní nemocnice Hradec Králové, Hradec Kralové

Fakultní nemocnice Brno, Brno

Všeobecná fakultní nemocnice v Praze, Prague

Centre Hospitalier de la Cote Basque, Bayonne

Centre Hospitalier Lyon Sud, Pierre-Bénite

Centre Hospitalier Universitaire Brest, Brest

Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou, Rennes

Hopital Hotel-Dieu - Service d'Hematologie, Nantes

Centre Henri-Becquerel, Rouen

Hôpital Claude Huriez, Lille

Hôpital Hôtel-Dieu, Nantes

Institut Paoli Calmettes, Marseille

Centre Hospitalier de Versailles, Le Chesnay

Hôpital Saint Louis, Paris

Hôpital Saint-Antoine, Paris

Universitätsklinik Heidelberg, Heidelberg

Universitätsklinikum Tübingen, Tübingen

Universitätsklinikum Ulm, Ulm

Medizinische Klinik der Universität Würzburg, Würzburg

Medizinische Hochschule Hannover, Hanover

Universitätsklinikum Aachen, Aachen

Universitätsklinikum Münster, Münster

Universitätsmedizin der Johannes Gutenberg Universität, Mainz

Universitätsklinikum des Saarlandes, Homburg / Saar

Klinikum Chemnitz gGmbH, Chemnitz

Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I, Dresden

Universitätsklinikum Leipzig, Leipzig

Universitätsklinikum Jena, Jena

Universitatsklinikum Freiburg, Freiburg im Breisgau

Universitätsklinikum Hamburg Eppendorf, Hamburg

Alexandra General Hospital, Athens

Pécsi Tudományegyetem, Pécs

Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, Kecskemét

Szegedi Tudományegyetem, Szeged

Debreceni Egyetem Klinikai Központ, Debrecen

Egyesített Szent István és Szent László Kórház-Rendelointézet, Budapest

Somogy Megyei Kaposi Mac okato Korhoz, Kaposvár

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

Rambam Health Corp., Haifa

Hadassah Medical Center, Jerusalem

Meir Medical Center, Kfar Saba

Tel Aviv Sourasky Medical Center, Tel Aviv

The Chaim Sheba Medical Center at Tel Hashomer, Tel Litwinsky

IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture, Rionero in Vulture

Azienda Ospedaliero-Univesitaria San Luigi Gonzaga, Orbassano

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna

Azienda Ospedaliera Spedali Civili di Brescia, Brescia

IRCCS Azienda Ospedaliera Universitaria San Martino, Genova

Azienda Ospedaliera Universitaria Maggiore della Carità, Novara

Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto, Piacenza

Azienda Ospedaliera Pisana Ospedale Santa Chiara, Pisa

Aienda Policknico Umberto I di Roma, Roma

Azienda Policknico Umberto l di Roma, Roma

Università Tor Vergata Ospedale Sant Eugenio, Roma

Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte, Siena

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

Nagoya City University Hospital, Nagoya

Toyohashi Municipal Hospital, Toyohashi

National Hospital Organization Kyushu Cancer Center, Fukuoka

Ogaki Municipal Hospital, Ōgaki

Gunma University Hospital, Maebashi

National Hospital Organization Nishigunma National Hospital, Shibukawa

Sapporo Medical University Hospital, Sapporo

Kobe City Medical Center General Hospital, Kobe

Tokai University Hospital, Isehara

Niigata Cancer Center Hospital, Niigata

Osaka University Hospital, Suita

Saitama Medical Center, Kawagoe

Tochigi Cancer Center, Utsunomiya

National Cancer Center Hospital, Chuo-ku

The Cancer Institute Hospital Of Japanese Foundation For Cancer Research, Koto-ku

Toranornon Hospital, Shinagawa

Tokyo Medical University Hospital, Shinjuku

National Hospital Organization Disaster Medical Center, Tachikawa

Kyushu University Hospital, Fukuoka

Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations, Kyoto

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

National Hospital Organization Okayama Medical Center, Okayama

Tokushima Prefectural Central Hospital, Tokushima

Japanese Red Cross Medical Center, Tokyo

North Shore Hospital, North Shore

Middlemore Hospital, Otahuhu

Auckland City Hospital, Grafton

Christchurch Hospital, Christchurch

Dunedin Hospital, Dunedin

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu, Poznan

Specjalistyczny Szpital Miejski im. Mikolaja Kopernika, Torun

Szpital Uniwersytecki w Krakowie, Krakow

Zamojski Szpital Niepubliczny Sp. z o.o., Zamość

Instytut Hematologii i Transfuzjologii, Warsaw

Uniwersyteckie Centrum Kliniczne, Gdansk

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich, Chorzów

Spitalul Universitar de Urgenta Bucuresti, Bucharest

Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie, Brasov

Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia), Brasov

Institutul Clinic Fundeni, Bucharest

Institutul Regional de Oncologie Iasi, Iași

Republican Clinical Hospital #1, Izhevsk

City Clinical Hospital n.a. S. P. Botkin, Moscow

"Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC Russian Railway", Moscow

Ryazan Regional Clinical Hospital, Ryazan

Clinical Hospital Number 31, Saint Petersburg

Federal Almazov Medical Research Centre, Saint Petersburg

FGU Russian Scientific Research Institute of Hematology and Transfusiology, Saint Petersburg

First Saint Petersburg I.P. Pavlov State Medical University, Saint Petersburg

GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin, Samara

National University Cancer Institute, Singapore

Singapore General Hospital, Singapore

Singapore Oncology Consultants, Singapore

Univerzitná nemocnica Bratislava, Bratislava

Gachon University Gil Medical Center, Incheon

Seoul National University Bundang Hospital, Seongnam-si

Pusan National University Hospital, Pusan

Kyungpook National University Hospital, Daegu

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Seoul Saint Mary's Hospital, Seoul

Severance Hospital, Yonsei University Health System, Seoul

Hospital Son Llàtzer, Palma de Mallorca

Hospital Universitari Germans Trias i Pujol, Badalona

Hospital Clinic I Provincial de Barcelona, Barcelona

Institut Universitari Dexeus, Barcelona

Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Princesa, Madrid

Hospital Clínico Universitario de Salamanca, Salamanca

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitari i Politecnic La Fé de Valencia, Valencia

Chang Gung Memorial Hospital, Kaohsiung City

China Medical University Hospital, Taichung

National Cheng-Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Chang Gung Medical Foundation-LinKou Branch, Taoyuan District

King Chulalongkorn Memorial Hospital, Bangkok

Ramathibodi Hospital, Bangkok

Srinagarind Hospital, Khon Kaen

City Hematology Center, Dnipro

"Municipal Institution of Health Protection Clinical Hospital #8", Kharkiv

Cherkassy Regional Oncology Center, Cherkassy

"MI Dnipropetrovsk City Multifield Clinical Hospital #4 of Dnipropetrovsk Regional Council, City Hematology Center", Dnipropetrovsk

Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences, Donetsk

Khmelnytsky Regional Clinical Hospital, Khmelnytsky

Khmelnytsky Regional Hospital, Department of Hematology, Khmelnytsky

National Institute of Cancer, Oncohematology Department, Kiev

Kyiv Bone Marrow Transplantation Center, Kyiv

Lviv Regional Oncology Dispensary, Lviv

Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy, Lviv

Regional Clinical Hospital, Mykolayiv

Royal Free Hospital, London

University College Hospital, London

Manchester Royal Infirmary, Manchester

Nottingham University Hospitals NHS Trust, Nottingham

Churchill Hospital, Oxford

Derriford Hospital, Plymouth

Royal Hallamshire Hospital, Sheffield

Royal Marsden Hospital, Surrey

Royal Wolverhampton Hospitals Trust, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY