A Phase IIA Trial Testing the Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
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
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete and partial remission, defined by the 2nd Workshop on Waldenstrom's macroglobulinemia
3 months and 6 months
No
Véronique LEBLOND, MD, PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
P060207
NCT00777738
October 2008
August 2012
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