Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2009-12-31
2019-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bortezomib consolidation
Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)
Bortezomib
1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
Interventions
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Bortezomib
1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 - 70 years
* Life expectancy \> 6 months
* Written informed consent
* Creatinine \< 400µmol/L
* Bilirubin \< 3x upper limit of normal
* WHO performance status 0-2
* Contraceptive precautions where appropriate
Exclusion Criteria
* On, or planned for, steroid therapy
* Poor performance status (ECOG ≥ 3)
* Disease progression at any stage
* Past history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2
* Severe hepatic impairment, indicated by bilirubin ≥ 3x upper limit of normal, or AST \> 2.5x upper limit of normal
* Pregnant or lactating women
* Allergic reaction attributable to bortezomib or to compounds containing boron or mannitol
* Severe cardiovascular disease
* History of acute infiltrative pulmonary or pericardial disease
* History of hypotension or has decreased blood pressure
* Peripheral neuropathy ≥ grade 2, or neuropathic pain
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Received any drugs or agents that inhibit or induce CYP2C19 or CYP3A4 within 14 days before the first dose of bortezomib
* Need for therapy with concomitant CYP 3A4 or CYP2C19 inhibitors
* Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
18 Years
70 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Kwee Yong
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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University College London
London, , United Kingdom
Countries
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Other Identifiers
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UCL/08/0170
Identifier Type: -
Identifier Source: org_study_id
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