Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
The study is an open randomized multicentre study in which patients with multiple myeloma
refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy,
in both arms with the addition of dexamethasone. In case of failure to the initially given
treatment the patient will be crossed over to the alternative treatment.
The number of patients needed is calculated to 300, based upon the hypothesis of a 50%
difference in progression free survival, a significance level of 95% and a power of 80%.
With 12 patients being recruited each month during 25 months and a 4 months follow-up after
the last included patient, the total study time will be 29 months.
The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards
recommendations for optimal dosing in the Nordic countries.
Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks,
thereafter every 6 weeks. Evaluation of efficacy is done according to The International
Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE
grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the
addition of the myeloma specific MY-24 module which are mailed to the patients at
predetermined intervals during the study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Martin Hjorth, MD, PhD
Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden
Sweden: Medical Products Agency