Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma
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