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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01568866




Registration number
NCT01568866
Ethics application status
Date submitted
28/03/2012
Date registered
2/04/2012
Date last updated
14/11/2022

Titles & IDs
Public title
Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
Scientific title
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
Secondary ID [1] 0 0
2012-000128-16
Secondary ID [2] 0 0
2011-003
Universal Trial Number (UTN)
Trial acronym
ENDEAVOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone

Experimental: 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.

Active comparator: 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.


Treatment: Drugs: Carfilzomib
Carfilzomib is administered over 30 minutes as an infusion.

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

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
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 outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Overall Response
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Percentage of Participants With = Grade 2 Peripheral Neuropathy
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)
Timepoint [5] 0 0
Baseline and 24 weeks
Secondary outcome [6] 0 0
Change From Baseline in Right Ventricular Fractional Area Change (FAC)
Timepoint [6] 0 0
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).
Secondary outcome [7] 0 0
Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)
Timepoint [7] 0 0
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).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/02/2018
Sample size
Target
Accrual to date
Final
929
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Public Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Saint George Hospital - Kogarah
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [6] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [9] 0 0
Haematology & Oncology Clinics of Australia - South Brisbane
Recruitment hospital [10] 0 0
Haematology and Oncology Clinics of Australia at Chermside - South Brisbane
Recruitment hospital [11] 0 0
Haematology and Oncology Clinics of Australia at Wesley - South Brisbane
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [14] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [15] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [16] 0 0
Saint Vincent's Hospital - East Melbourne
Recruitment hospital [17] 0 0
Western Hospital - Footscray
Recruitment hospital [18] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [19] 0 0
Sunshine Hospital - St. Albans
Recruitment hospital [20] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [21] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Camperdown
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- Darlinghurst
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- Kogarah
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- Liverpool
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- Saint Leonards
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- Waratah
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- Westmead
Recruitment postcode(s) [8] 0 0
- Herston
Recruitment postcode(s) [9] 0 0
- South Brisbane
Recruitment postcode(s) [10] 0 0
- Adelaide
Recruitment postcode(s) [11] 0 0
- Woodville
Recruitment postcode(s) [12] 0 0
- Box Hill
Recruitment postcode(s) [13] 0 0
- Clayton
Recruitment postcode(s) [14] 0 0
- East Melbourne
Recruitment postcode(s) [15] 0 0
- Footscray
Recruitment postcode(s) [16] 0 0
- Melbourne
Recruitment postcode(s) [17] 0 0
- St. Albans
Recruitment postcode(s) [18] 0 0
- Fremantle
Recruitment postcode(s) [19] 0 0
- Perth
Recruitment outside Australia
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California
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Colorado
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Tennessee
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Texas
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Utah
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Austria
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Tyrol
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Vienna
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Nova Scotia
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Praha
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Czechia
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Severomoravsky KRAJ
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Rheinland-pfalz
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Sachsen
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Thuringen
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Freiburg
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Hamburg
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Greece
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Attica
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Bacs-kiskun
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Baranya
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Csongrad
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Hajdu-bihar
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Budapest
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Kaposvár
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Potenza
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Italy
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Torino
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Italy
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Ancona
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Bologna
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Brescia
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Italy
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Genova
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Italy
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Novara
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Italy
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Piacenza
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Italy
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Pisa
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Italy
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Roma
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Italy
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Siena
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Aichi
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Fukuoka
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Gifu
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Gunma
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Hokkaido
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Hyogo
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Kanagawa
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Niigata
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Osaka
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Tochigi
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Tokyo
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Kyoto
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Okayama
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Tokushima
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangnam-Do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Auckland
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New Zealand
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Aukland
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Malopolskie
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Mazowieckie
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Pomorskie
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Poland
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Slaskie
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Poland
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Wielkopolskie
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Romania
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Bucuresti
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Romania
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Brasov
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Romania
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Iasi
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Singapore
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Singapore
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Slovakia
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Bratislava
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Spain
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Baleares
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Tao-Yuan
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Thailand
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Bangkok Metropolis
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Thailand
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Khon Kaen
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Ukraine
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Dnipropretrovsk
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Ukraine
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Kharkiv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Cherkassy
Country [143] 0 0
Ukraine
State/province [143] 0 0
Dnipropetrovsk
Country [144] 0 0
Ukraine
State/province [144] 0 0
Donetsk
Country [145] 0 0
Ukraine
State/province [145] 0 0
Khmelnytsky
Country [146] 0 0
Ukraine
State/province [146] 0 0
Kiev
Country [147] 0 0
Ukraine
State/province [147] 0 0
Kyiv
Country [148] 0 0
Ukraine
State/province [148] 0 0
Lviv
Country [149] 0 0
Ukraine
State/province [149] 0 0
Mykolayiv
Country [150] 0 0
United Kingdom
State/province [150] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01568866