Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
The purpose of the study is to compare thalidomide + dexamethasone with bortezomib +
 dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main
 goal is to find out which of these two 2:nd line regimens that offers the patients the best
 chance for a response with as long duration and as good quality of life as possible.
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.
Inclusion Criteria:

 -  Treatment demanding multiple myeloma

 -  Refractoriness to melphalan

 -  Acceptance of rules for prevention of pregnancy

 Exclusion Criteria:

 -  Previous treatment with bortezomib, thalidomide, or lenalidomide

 -  Sensory neuropathy grade III or neuropathic pain grade II

 -  Severe concomitant disorder, e.g. other malignancy or severe heart disease

 -  Transformation to plasma cell leukemia or aggressive lymphoma

 -  Frequent visits for bortezomib injections not feasible

 -  Anticipated non-adherence to study protocol

 -  Pregnancy

 -  Anticipated non-adherence to rules for prevention of pregnancy

 -  Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)