Clinical trial NCT01818752: Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
Official title: A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 955
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group \[IMWG\] diagnostic criteria)
2. Transplant ineligibility
3. Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization):

   * Serum M-protein ≥ 0.5 g/dL, or
   * Urine M-protein ≥ 200 mg/24 hours, or
   * In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio \< 0.26 or \> 1.65)
4. No prior treatment for multiple myeloma
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

1. Multiple myeloma of IgM (immunoglobulin M) subtype
2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
4. Plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
5. Waldenström macroglobulinemia (WM)
6. Known amyloidosis

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.
measure: Overall Response Rate
timeFrame: Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
measure: Complete Response Rate
timeFrame: Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.
measure: Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
timeFrame: From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
measure: European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
timeFrame: Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: California Cancer Associates for Research & Excellence, Inc. (cCARE)
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Modesto
country: United States
facility: Sutter Gould Medical Foundation
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Gainesville
country: United States
facility: UF Health Shands Cancer Hospital
state: Florida
city: Evanston
country: United States
facility: Evanston KelIogg Cancer Center
state: Illinois
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Brooklyn
country: United States
facility: Maimonides Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Greenville
country: United States
facility: Saint Francis Health System
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Healthcare System
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology Oncology
state: South Carolina
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)
city: Santa Fe
country: Argentina
facility: Sanatorio Britanico S.A.
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: North Gosford
country: Australia
facility: Central Coast Local Health District
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Health - Box Hill Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: New South Wales
country: Australia
facility: Royal North Shore Hospital, Haematology Department
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, University Clinic for Internal Medicine V
city: Linz
country: Austria
facility: Elisabeth Linz Hospital
city: Vienna
country: Austria
facility: Vienna Wilhelminen Hospital
city: Antwerp
country: Belgium
facility: ZNA, Stuivenberg
state: Antwerpen
city: Arlon
country: Belgium
facility: Saint Joseph Clinic Arlon, Department of Hematology
state: Luxembourg
city: Liège
country: Belgium
facility: CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic
city: Sofia
country: Bulgaria
facility: Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Sveta Marina", Varna
city: Greenfield Park
country: Canada
facility: CSSS-Champlain-Charles LeMoyne
state: Quebec
city: Fuzhou City
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'an City
country: China
facility: The First Affiliated Hospital of the Fourth Military Medical University of PLA
state: Shanxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: 307 Hospital of PLA
city: Beijing
country: China
facility: Beijing Chao Yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Shanghai
country: China
facility: Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Tianjin
country: China
facility: Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Brno
country: Czechia
facility: University Hospital Brno, Department of Internal Hematology and Oncology
city: Brno
country: Czechia
facility: University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology
city: Ostrava
country: Czechia
facility: University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO
city: Prague
country: Czechia
facility: University Hospital Kralovske Vinohrady - Internal Hematology Clinic
city: Prague
country: Czechia
facility: General University Hospital Prague, 1st Department of Medicine - Department of Hematology
city: Caen Cedex 9
country: France
facility: CHU de Caen, Côte de Nacre
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Dijon
country: France
facility: UHC Dijon, Children's Hospital
city: Lille Cedex
country: France
facility: CHRU Hopital Huriez, Departement of Hematology
city: Lille
country: France
facility: CHRU Lille Hôpital Claude Huriez
city: Marseille cedex
country: France
facility: Paoli Calmettes Institute, Department ofHematology 2
city: Nantes Cedex 1
country: France
facility: Nantes University Hospital Center
city: Nimes cedex 9
country: France
facility: Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau
city: Paris
country: France
facility: Hopital Saini Louis, Service d'immuno-Hematologie
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hospital Necker
city: Pierre Bénite, cedex
country: France
facility: South Lyon Hospital Center
city: Pierre Bénite, Cedex
country: France
facility: Centre Hospitalier Lyon Sud, Service d'hématologie Clinique
city: Rennes Cedex 9
country: France
facility: Hopital Pontchaillou
city: Toulouse Cedex 9
country: France
facility: Hospital Purpan
city: Tours Cedex 1
country: France
facility: CHU de Tours Hopital Bretonneau
city: Freiburg
country: Germany
facility: Freiburg University Medical Center
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III
state: Baden-Wuerttemberg
city: Munich
country: Germany
facility: Ludwig Maximilians University Hospital - Medical Clinic III
state: Bavaria
city: Cologne
country: Germany
facility: University Hospital Cologne
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III
state: Rhineland-Palatinate
city: Homburg / Saar
country: Germany
facility: Saarland University Hospital
state: Saarland
city: Dresden
country: Germany
facility: Group Practice for Hematology and Oncology
city: Koblenz
country: Germany
facility: Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine
city: Athens
country: Greece
facility: Evangelismos Hospital
state: Attica
city: Athens
country: Greece
facility: University of Athens, Alexandra Hospital
city: Budapest
country: Hungary
facility: St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant
city: Budapest
country: Hungary
facility: National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology
city: Gyula
country: Hungary
facility: Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology
city: Kaposvar
country: Hungary
facility: Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine
city: Pecs
country: Hungary
facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center, Department of Hematology
city: Jerusalem
country: Israel
facility: Ein Kerem Hospital, Department of Hematology
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Genova
country: Italy
facility: UO Clinica Ematologica, IRCCS A.O.U. San Martino
state: GE
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga
state: TO
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi
city: Novara
country: Italy
facility: Maggiore della Carita Hospital of Novara
city: Piacenza
country: Italy
facility: Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Rome
country: Italy
facility: Policlinico Universitario "Umberto I"
city: Torino
country: Italy
facility: AO Città della Salute e della Scienza di Torino, Division of Hematology
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
state: Fukuoka-Ken
city: Minami-ku
country: Japan
facility: National Hospitalization Organization Kyushu Cancer Center
state: Fukuoka
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidou
city: Okayama-city
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
state: Shibuya-ku
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Koto
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research
state: Tokyo
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine
state: Tokyo
city: Tachikawa-city
country: Japan
facility: National Hospital Organization Disaster Medical Center
state: Tokyo
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Tokushima
country: Japan
facility: Tokushima Prefectural Central Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo Leon
city: Mendoza
country: Mexico
facility: Fundacion Centro Oncologieo de Integracion Regional - COIR
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Puebla
country: Mexico
facility: Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis, Department of Hematology
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Zwolle
country: Netherlands
facility: Isala Clinics in Zwolle, Department of Oncology
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Canterbury Health Laboratories
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Olsztyn
country: Poland
facility: Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn
state: OIsztyn
city: Chorzow
country: Poland
facility: Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology
state: Slaskie
city: Katowice
country: Poland
facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice
city: Krakow
country: Poland
facility: Independent Public Healthcare Facility University Hospital
city: Lodz
country: Poland
facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital
city: Lublin
country: Poland
facility: Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology
city: Torun
country: Poland
facility: Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: "Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department
state: Cluj County
city: Iasi
country: Romania
facility: Iasi Regional Institute for Oncology, Medical Hematology Department
state: Iasi County
city: Brasov
country: Romania
facility: Brasov County Emergency Clinical Hospital, Hematology Department
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute, Hematology Department
city: Bucharest
country: Romania
facility: Coltea Clinical Hospital, Hematology Department
city: Bucharest
country: Romania
facility: Bucharest Emergency University Hospital, Hematology Department
city: Targu-Mures
country: Romania
facility: Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation
city: Petrozavodsk
country: Russian Federation
facility: State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology
state: Republic Of Karelia
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2
city: Izhevsk
country: Russian Federation
facility: State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
city: Moscow
country: Russian Federation
facility: Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
city: Saint Petersburg
country: Russian Federation
facility: State Higher Educational Institution St. Petersburg Pavlov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian
city: St. Petersburg
country: Russian Federation
facility: Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Singapore Oncology Consultants, Gleneagles Hospital
city: Singapore
country: Singapore
facility: OncoCare Cancer Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barselona
city: Pamplona
country: Spain
facility: University Hospital of Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Salamanca
country: Spain
facility: Hospital Universitario, Salamanca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio University
city: Valencia
country: Spain
facility: Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología
city: Zaragoza
country: Spain
facility: Hospital Quiron Zaragoza
city: Lausanne
country: Switzerland
facility: University Hospital Center Vaudois
city: Saint Gallen
country: Switzerland
facility: County Hospital Saint Gallen
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kuohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Tapei
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
state: Bornova
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department
state: Cebeci
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
state: Pendik
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Center
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Oncology Center, Department of Hematology
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi Regional Hospital, Hematology Department
city: Kyiv
country: Ukraine
facility: Kyiv Center for Bone Marrow Transplantation
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine
city: Poltava
country: Ukraine
facility: Poltava M.V. Sklifosovskyi Regional Clinical-Hospital
city: Uzhgorod
country: Ukraine
facility: A. Novak Zakarpattia Regional Clinical Hospital
city: Vinnitsya
country: Ukraine
facility: M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department
city: Zhytomyr
country: Ukraine
facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: Kent
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital, Kent Oncology Centre
state: Kent
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: London
country: United Kingdom
facility: University College London, Cancer Centre
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust, Churchill Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.
citation: Facon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.
citation: Rosenthal A, Luthi J, Belohlavek M, Kortum KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6(1):e384. doi: 10.1038/bcj.2015.112.