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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
University College London
London, United Kingdom
Change in Disease response
Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.
Time frame: At 6 and 12 months after ASCT consolidated by bortezomib therapy
Number of patients with adverse events
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
Time frame: Up to 8 months after treatment start
assess effect of bortezomib consolidation on bone health
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
Time frame: At 1, 2, 3 and 9 months after start of treatment
assess the effect of bortezomib consolidation on Minimal Residue Disease status
Time frame: At 6 and 12 months post ASCT
determine progression free survival
Time frame: At 2 years post ASCT
evaluate the quality of life for patients receiving bortezomib consolidation
Time frame: Up to 8 months after treatment start
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.