Status:
COMPLETED
Bortezomib Consolidation Trial
Lead Sponsor:
University College, London
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will als...
Eligibility Criteria
Inclusion
- MM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed
- 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
- Received bortezomib previously
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01517724
Start Date
December 1 2009
End Date
January 24 2019
Last Update
April 17 2019
Active Locations (1)
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1
University College London
London, United Kingdom