This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of proteasome used in multiple myeloma, in patients with advanced Waldenström's Macroglobulinemia disease.
Open, prospective, multicenter, non controlled phase IIA trial Primary objectives Evaluation of the efficacy and safety of Velcade in monotherapy for patients with advanced stage Waldenström Macroglobulinemia. Secondary objectives Evaluation of the activity of the association of High Dose Dexamethasone (HD DXM) with Velcade for patients resistant to Velcade Alone For all patients * Overall survival * Safety * Quality of life * Duration of response sample size: With type I error alpha of 5% and type II error beta of 20% and a two-sided test, the number of patients needed in this study is 34 Number of centers: 28 Centers participating to the French cooperative group CLL/WM
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
* Bortezomib (Velcade(R)): 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days for 2 cycles (IV route, push). * For responding patients : up to 6 cycles * For non responding patient : Adjunction of dexamethasone (HD DXM) : 20 mg Days 1,D2, D 4,D 5, D8, D9 and D 11,D12 every 21 days
Hopital La Pitie Salpetriere
Paris, France
Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia
Time frame: 3 months and 6 months
Duration of the response
Time frame: during the study
Overall survival
Time frame: during the study
Quality of life
Time frame: months 0, 3, 12, 24
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