Clinical trial NCT01568866: Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
Official title: A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: multiple myeloma
relapsed multiple myeloma
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 929
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 of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.


Eligibility criteria: Inclusion Criteria:

1. Multiple myeloma with relapsing or progressing disease at study entry.
2. Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization):

   * Serum M-protein ≥ 0.5 g/dL, or
   * Urine M-protein ≥ 200 mg/24 hour, or
   * In patients without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or
   * For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL).
3. Patients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.
4. Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
5. Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).
6. Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
7. Males and females ≥ 18 years of age.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
9. Adequate hepatic function within 21 days prior to randomization, with bilirubin \< 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times the ULN.
10. Left ventricular ejection fraction (LVEF) ≥ 40%.
11. Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.
12. Hemoglobin ≥ 8.0 g/dL within 21 days prior to randomization. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.
13. Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is \> 50%) within 21 days prior to randomization. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
14. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault:

    \[(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)\]; multiply result by 0.85 if female.
15. Written informed consent in accordance with federal, local, and institutional guidelines.
16. Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to randomization and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
17. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.

Exclusion Criteria:

1. Multiple Myeloma of IgM subtype.
2. Glucocorticoid therapy (prednisone \> 30 mg/day or equivalent) within 14 days prior to randomization.
3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
4. Plasma cell leukemia or circulating plasma cells ≥ 2 × 10\^9/L.
5. Waldenstrom's Macroglobulinemia.
6. Patients with known amyloidosis.
7. Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
8. Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
9. Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
10. Immunotherapy within 21 days prior to randomization.
11. Major surgery (excluding kyphoplasty) within 28 days prior to randomization.
12. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.
13. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
14. Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen \[SAg\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
15. Patients with known cirrhosis.
16. Second malignancy within the past 3 years except:

    * adequately treated basal cell or squamous cell skin cancer
    * carcinoma in situ of the cervix
    * prostate cancer \< Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
    * breast carcinoma in situ with full surgical resection
    * treated medullary or papillary thyroid cancer
17. Patients with myelodysplastic syndrome.
18. Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
19. Female patients who are pregnant or lactating.
20. Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib).
21. Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol.
22. Patients with contraindication to dexamethasone.
23. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
24. Ongoing graft-vs-host disease.
25. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.

Primary outcomes:
measure: Progression-free Survival
timeFrame: From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively
Secondary outcomes:
measure: Overall Survival
timeFrame: From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.
measure: Overall Response
timeFrame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
measure: Duration of Response
timeFrame: From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.
measure: Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
timeFrame: From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.
measure: Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in Right Ventricular Fractional Area Change (FAC)
timeFrame: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
measure: Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)
timeFrame: Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Moore Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Group
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Melbourne
country: United States
facility: MAB Oncology/Hematology
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Indianapolis
country: United States
facility: Hematology Oncology of Indiana, PC
state: Indiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Rockville
country: United States
facility: Associates in Oncology/Hematology PC
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kansas City
country: United States
facility: University of Kansas
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Ctr
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Clinical Research Alliance Inc.
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences, Section on Hematology and Oncology
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Hematology/Oncology Associates of SC
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Houston
country: United States
facility: The Methodist Cancer Center
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Public Hospital Sydney
state: New South Wales
city: Kogarah
country: Australia
facility: Saint George Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Haematology & Oncology Clinics of Australia
state: Queensland
city: South Brisbane
country: Australia
facility: Haematology and Oncology Clinics of Australia at Chermside
state: Queensland
city: South Brisbane
country: Australia
facility: Haematology and Oncology Clinics of Australia at Wesley
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Saint Vincent's Hospital
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: St. Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
state: Tyrol
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung
state: Upper Austria
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien
state: Vienna
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
state: Flemish Brabant
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne
state: Namur
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-vlaanderen
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer
state: RIO Grande DO Norte
city: Porto Alegre
country: Brazil
facility: Clínica de Oncologia de Porto Alegre
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: RIO Grande DO SUL
city: Campinas
country: Brazil
facility: Hemocentro Campinas-Unicamp
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
city: Rio de Janeiro
country: Brazil
facility: Instituto Centros Oncológicos Integrados de Educação e Pesquisa
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Câncer-INCA
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
city: Sofia
country: Bulgaria
facility: Military Medical Academy Hospital for Active Treatment
state: Sofiya
city: Sofia
country: Bulgaria
facility: Shato, Ead
state: Sofiya
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment, "Sveta Marina''
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Science Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Praha 10
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
state: Praha
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
state: Severomoravsky KRAJ
city: Ostrava
country: Czechia
facility: FN Ostrava
state: Severomoravsky KRAJ
city: Hradec Kralové
country: Czechia
facility: Fakultní nemocnice Hradec Králové
state: Vychodocesky KRAJ
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
state: Aquitaine
city: Brest Cedex
country: France
facility: Centre Hospitalier Universitaire Brest
state: Bretagne
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
state: Bretagne
city: Nantes
country: France
facility: Hopital Hotel-Dieu - Service d'Hematologie
state: Cedex 1
city: Rouen Cedex 1
country: France
facility: Centre Henri-Becquerel
state: Haute-normandie
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
state: Ile-de-france
city: Paris
country: France
facility: Hôpital Saint Louis
state: Ile-de-france
city: Paris
country: France
facility: Hôpital Saint-Antoine
state: Ile-de-france
city: Lille Cedex
country: France
facility: Hôpital Claude Huriez
state: NORD Pas-de-calais
city: Nantes cedex 1
country: France
facility: Hôpital Hôtel-Dieu
state: PAYS DE LA Loire
city: Marseille Cedex 9
country: France
facility: Institut Paoli Calmettes
state: Provence Alpes COTE D'azur
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone-alpes
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg
state: Baden-wuerttemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-wuerttemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-wuerttemberg
city: Würzburg
country: Germany
facility: Medizinische Klinik der Universität Würzburg
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: Nordrhein-westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität
state: Rheinland-pfalz
city: Homburg / Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thuringen
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Athens
country: Greece
facility: Alexandra General Hospital
state: Attica
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
state: Bacs-kiskun
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
state: Hajdu-bihar
city: Budapest
country: Hungary
facility: Egyesített Szent István és Szent László Kórház-Rendelointézet
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mac okato Korhoz
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Haifa
country: Israel
facility: Rambam Health Corp.
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center at Tel Hashomer
city: Rionero in Vulture
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
state: Potenza
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
state: Torino
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore della Carità
city: Piacenza
country: Italy
facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana Ospedale Santa Chiara
city: Roma
country: Italy
facility: Aienda Policknico Umberto I di Roma
city: Roma
country: Italy
facility: Azienda Policknico Umberto l di Roma
city: Roma
country: Italy
facility: Università Tor Vergata Ospedale Sant Eugenio
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Nagoya City
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Fukuoka-city
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Ogaki City
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Shibukawa
country: Japan
facility: National Hospital Organization Nishigunma National Hospital
state: Gunma
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Niigata-city
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of Japanese Foundation For Cancer Research
state: Tokyo
city: Shinagawa
country: Japan
facility: Toranornon Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Tachikawa
country: Japan
facility: National Hospital Organization Disaster Medical Center
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kyoto
country: Japan
facility: Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Tokushima
country: Japan
facility: Tokushima Prefectural Central Hospital
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Gyeonggi-Do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Gyeongsangnam-Do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: North Shore City
country: New Zealand
facility: North Shore Hospital
state: Auckland
city: Otahuhu
country: New Zealand
facility: Middlemore Hospital
state: Auckland
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Aukland
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Torun
country: Poland
facility: Specjalistyczny Szpital Miejski im. Mikolaja Kopernika
state: Kujawsko-Pomorskie
city: Zamosc
country: Poland
facility: Zamojski Szpital Niepubliczny Sp. z o.o.
state: Lubelskie
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
state: Malopolskie
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Chorzów
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
state: Slaskie
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
state: Wielkopolskie
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
state: Bucuresti
city: Brasov
country: Romania
facility: Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Izhevsk
country: Russian Federation
facility: Republican Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. S. P. Botkin
city: Moscow
country: Russian Federation
facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: Clinical Hospital Number 31
city: Saint Petersburg
country: Russian Federation
facility: Federal Almazov Medical Research Centre
city: Saint Petersburg
country: Russian Federation
facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology
city: Saint Petersburg
country: Russian Federation
facility: First Saint Petersburg I.P. Pavlov State Medical University
city: Samara
country: Russian Federation
facility: GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin
city: Singapore
country: Singapore
facility: National University Cancer Institute
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Singapore Oncology Consultants
city: Bratislava
country: Slovakia
facility: Univerzitná nemocnica Bratislava
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Baleares
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fé de Valencia
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Tao-Yuan
country: Taiwan
facility: Chang Gung Medical Foundation-LinKou Branch
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok Metropolis
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
state: Bangkok Metropolis
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Dnepropetrovsk
country: Ukraine
facility: City Hematology Center
state: Dnipropretrovsk
city: Kharkov
country: Ukraine
facility: Municipal Institution of Health Protection "Clinical Hospital #8"
state: Kharkiv
city: Cherkassy
country: Ukraine
facility: Cherkassy Regional Oncology Center
city: Dnipropetrovsk
country: Ukraine
facility: MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center
city: Donetsk
country: Ukraine
facility: Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences
city: Khmelnytsky
country: Ukraine
facility: Khmelnytsky Regional Clinical Hospital
city: Khmelnytsky
country: Ukraine
facility: Khmelnytsky Regional Hospital, Department of Hematology
city: Kiev
country: Ukraine
facility: National Institute of Cancer, Oncohematology Department
city: Kyiv
country: Ukraine
facility: Kyiv Bone Marrow Transplantation Center
city: Lviv
country: Ukraine
facility: Lviv Regional Oncology Dispensary
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy
city: Mykolayiv
country: Ukraine
facility: Regional Clinical Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
state: England
city: London
country: United Kingdom
facility: University College Hospital
state: England
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: England
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: England
city: Surrey
country: United Kingdom
facility: Royal Marsden Hospital
state: England
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospitals Trust
state: England
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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