Bortezomib Consolidation Trial (BCT)

Inclusion Criteria:

• 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 Criteria:

• 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