6 Recommendations for further research
6.1 The Committee considered that further research into the effectiveness of bortezomib for the treatment of relapsed multiple myeloma is needed. Such studies should include:
comparisons with other agents that are currently used in clinical practice in the NHS in England and Wales
a robust design, adequate sample size and appropriate statistical analysis
assessment of long-term prognosis, for which observational studies would be appropriate
measurement of quality of life in patients with relapsed multiple myeloma, including the effect of treatment and adverse events
a consideration of subgroups of patients in whom bortezomib might be particularly effective.
6.2 The Committee recommended that further research should be carried out to establish the survival benefit in patients treated with bortezomib at first relapse whose disease responds minimally (that is 25–49% reduction in serum M protein) and compare this with that in complete and partial responders.