Bortezomib Consolidation Trial (BCT)

• Change in Disease response [ Time Frame: At 6 and 12 months after ASCT consolidated by bortezomib therapy ] [ Designated as safety issue: No ]
  Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.
• Number of patients with adverse events [ Time Frame: Up to 8 months after treatment start ] [ Designated as safety issue: Yes ]
  The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT

• assess effect of bortezomib consolidation on bone health [ Time Frame: At 1, 2, 3 and 9 months after start of treatment ] [ Designated as safety issue: No ]
  Summary of changes from baseline, after cycle 1,2 and 3 of bortezomib treatment and at the end of treatment for markers of bone formation and resorption
• assess the effect of bortezomib consolidation on Minimal Residue Disease status [ Time Frame: At 6 and 12 months post ASCT ] [ Designated as safety issue: No ]
• determine progression free survival [ Time Frame: At 2 years post ASCT ] [ Designated as safety issue: No ]
• evaluate the quality of life for patients receiving bortezomib consolidation [ Time Frame: Up to 8 months after treatment start ] [ Designated as safety issue: No ]

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 also assess the effect of bortezomib treatment on patient bone health.

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