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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 October 2012 |
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Main ID: |
EUCTR2004-004871-12-IT |
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Date of registration:
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07/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-Amyloidosis
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Scientific title:
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An Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-Amyloidosis |
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Date of first enrolment:
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02/05/2005 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004871-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Systemic AL-Amyloidosis
MedDRA version: 6.1
Level: PT
Classification code 10002022
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Intervention(s)
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Trade Name: VELCADE*1FL 3,5MG
Product Name: NA
Product Code: NA
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective:
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Primary end point(s):
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Secondary ID(s)
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26866138-CAN-2007
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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