A Phase 3 interventional study of Bortezomib and Thalidomide in Multiple Myeloma, sponsored by Nordic Myeloma Study Group. Completed at 27 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-09.
Sponsored by Nordic Myeloma Study Group · Phase 3, Interventional, and Treatment
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.
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's planned enrollment of 300 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Nordic Myeloma Study Group is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Bortezomib - dexamethasone
Drug: Bortezomib
Thalidomide - dexamethasone
Drug: Thalidomide
Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity
Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity
Progression free survival
Response rate
Response duration
Time to start of other treatment
Toxicity
Quality of life
Response rate after cross-over
Response duration after cross-over
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thalidomide
Nordic Myeloma Study Group