Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
NCT ID: NCT01568866
Last Updated: 2022-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
929 participants
INTERVENTIONAL
2012-06-20
2018-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Carfilzomib plus Dexamethasone
Participants received 20 mg/m² carfilzomib administered by intravenous (IV) infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
Carfilzomib
Carfilzomib is administered over 30 minutes as an infusion.
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.
Bortezomib plus Dexamethasone
Participants received bortezomib 1.3 mg/m² administered IV or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Bortezomib
Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)
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.
Interventions
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Carfilzomib
Carfilzomib is administered over 30 minutes as an infusion.
Bortezomib
Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Providence St. Joseph Medical Center
Burbank, California, United States
UCSD Moore Cancer Center
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Central Coast Medical Oncology Group
Santa Maria, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
MAB Oncology/Hematology
Melbourne, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Hematology Oncology of Indiana, PC
Indianapolis, Indiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Associates in Oncology/Hematology PC
Rockville, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Kansas
Kansas City, Missouri, United States
Hackensack University Medical Ctr
Hackensack, New Jersey, United States
Clinical Research Alliance Inc.
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences, Section on Hematology and Oncology
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Hematology/Oncology Associates of SC
Greenville, South Carolina, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
The Methodist Cancer Center
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St. Vincent's Public Hospital Sydney
Darlinghurst, New South Wales, Australia
Saint George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Haematology & Oncology Clinics of Australia
South Brisbane, Queensland, Australia
Haematology and Oncology Clinics of Australia at Chermside
South Brisbane, Queensland, Australia
Haematology and Oncology Clinics of Australia at Wesley
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Saint Vincent's Hospital
East Melbourne, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz, Upper Austria, Austria
Wilhelminenspital der Stadt Wien
Vienna, Vienna, Austria
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen
Antwerp, , Belgium
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Clínica de Oncologia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hemocentro Campinas-Unicamp
Campinas, São Paulo, Brazil
Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
Rio de Janeiro, , Brazil
Instituto Centros Oncológicos Integrados de Educação e Pesquisa
Rio de Janeiro, , Brazil
Instituto Nacional do Câncer-INCA
Rio de Janeiro, , Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, , Brazil
Military Medical Academy Hospital for Active Treatment
Sofia, Sofia, Bulgaria
Shato, Ead
Sofia, Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment, "Sveta Marina''
Varna, , Bulgaria
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Kelowna, British Columbia, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Fakultní nemocnice Královské Vinohrady
Prague, Prague, Czechia
Fakultní nemocnice Olomouc
Olomouc, Severomoravsky KRAJ, Czechia
FN Ostrava
Ostrava, Severomoravsky KRAJ, Czechia
Fakultní nemocnice Hradec Králové
Hradec Kralové, Vychodocesky KRAJ, Czechia
Fakultní nemocnice Brno
Brno, , Czechia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Centre Hospitalier de la Cote Basque
Bayonne, Aquitaine, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire Brest
Brest, Brittany Region, France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, Brittany Region, France
Hopital Hotel-Dieu - Service d'Hematologie
Nantes, Cedex 1, France
Centre Henri-Becquerel
Rouen, Haute-normandie, France
Hôpital Claude Huriez
Lille, Hauts-de-France, France
Hôpital Hôtel-Dieu
Nantes, Pays de la Loire Region, France
Institut Paoli Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de Versailles
Le Chesnay, Île-de-France Region, France
Hôpital Saint Louis
Paris, Île-de-France Region, France
Hôpital Saint-Antoine
Paris, Île-de-France Region, France
Universitätsklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Medizinische Klinik der Universität Würzburg
Würzburg, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I
Dresden, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Alexandra General Hospital
Athens, Attica, Greece
Pécsi Tudományegyetem
Pécs, Baranya, Hungary
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
Kecskemét, Bács-Kiskun county, Hungary
Szegedi Tudományegyetem
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary
Egyesített Szent István és Szent László Kórház-Rendelointézet
Budapest, , Hungary
Somogy Megyei Kaposi Mac okato Korhoz
Kaposvár, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Rambam Health Corp.
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center at Tel Hashomer
Tel Litwinsky, , Israel
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
Orbassano, Torino, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Azienda Ospedaliera Universitaria Maggiore della Carità
Novara, , Italy
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, , Italy
Azienda Ospedaliera Pisana Ospedale Santa Chiara
Pisa, , Italy
Aienda Policknico Umberto I di Roma
Roma, , Italy
Azienda Policknico Umberto l di Roma
Roma, , Italy
Università Tor Vergata Ospedale Sant Eugenio
Roma, , Italy
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Siena, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
National Hospital Organization Nishigunma National Hospital
Shibukawa, Gunma, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Osaka University Hospital
Suita, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of Japanese Foundation For Cancer Research
Koto-ku, Tokyo, Japan
Toranornon Hospital
Shinagawa, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku, Tokyo, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, Japan
Kyushu University Hospital
Fukuoka, , Japan
Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations
Kyoto, , Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Tokushima Prefectural Central Hospital
Tokushima, , Japan
Japanese Red Cross Medical Center
Tokyo, , Japan
North Shore Hospital
North Shore, Auckland, New Zealand
Middlemore Hospital
Otahuhu, Auckland, New Zealand
Auckland City Hospital
Grafton, Aukland, New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Specjalistyczny Szpital Miejski im. Mikolaja Kopernika
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Zamojski Szpital Niepubliczny Sp. z o.o.
Zamość, Lublin Voivodeship, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów, Silesian Voivodeship, Poland
Spitalul Universitar de Urgenta Bucuresti
Bucharest, București, Romania
Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie
Brasov, , Romania
Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)
Brasov, , Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Republican Clinical Hospital #1
Izhevsk, , Russia
City Clinical Hospital n.a. S. P. Botkin
Moscow, , Russia
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
Moscow, , Russia
Ryazan Regional Clinical Hospital
Ryazan, , Russia
Clinical Hospital Number 31
Saint Petersburg, , Russia
Federal Almazov Medical Research Centre
Saint Petersburg, , Russia
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, , Russia
First Saint Petersburg I.P. Pavlov State Medical University
Saint Petersburg, , Russia
GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin
Samara, , Russia
National University Cancer Institute
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Singapore Oncology Consultants
Singapore, , Singapore
Univerzitná nemocnica Bratislava
Bratislava, , Slovakia
Gachon University Gil Medical Center
Incheon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Hospital
Pusan, Gyeongsangnam-do, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
Institut Universitari Dexeus
Barcelona, , Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fé de Valencia
Valencia, , Spain
Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng-Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-LinKou Branch
Taoyuan District, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok Metropolis, Thailand
Ramathibodi Hospital
Bangkok, Bangkok Metropolis, Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
City Hematology Center
Dnipro, Dnipropretrovsk, Ukraine
Municipal Institution of Health Protection "Clinical Hospital #8"
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Cherkassy Regional Oncology Center
Cherkassy, , Ukraine
MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center
Dnipropetrovsk, , Ukraine
Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences
Donetsk, , Ukraine
Khmelnytsky Regional Clinical Hospital
Khmelnytsky, , Ukraine
Khmelnytsky Regional Hospital, Department of Hematology
Khmelnytsky, , Ukraine
National Institute of Cancer, Oncohematology Department
Kiev, , Ukraine
Kyiv Bone Marrow Transplantation Center
Kyiv, , Ukraine
Lviv Regional Oncology Dispensary
Lviv, , Ukraine
Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy
Lviv, , Ukraine
Regional Clinical Hospital
Mykolayiv, , Ukraine
Royal Free Hospital
London, England, United Kingdom
University College Hospital
London, England, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Royal Marsden Hospital
Surrey, England, United Kingdom
Royal Wolverhampton Hospitals Trust
Wolverhampton, England, United Kingdom
Countries
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References
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Other Identifiers
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2012-000128-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2011-003
Identifier Type: -
Identifier Source: org_study_id
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