Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom's Macroglobulinemia
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Rituximab is a monoclonal antibody with proven efficacy in WM but responses are slow.
Bortezomib has shown significant and rapid activity in WM. Combinations of bortezomib with
rituximab nad dexamethasone with rituximab have shown synergistic activity in laboratory
studies and clinical trials. This is a Phase II multicenter study designed to evaluate the
safety and efficacy of the combination of Bortezomib , Rituximab and dexamethasone (BDR). BDR
will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles
to patients with WM. Bortezomib will be administered as an iv push over 3 to 5 seconds at a
dose of 1.3mg/m2/day on days 1,4,8 and 11 of cycle 1. On cycles 2-5 bortezomib will be given
at a dose of 1.6mg/m2/day on days 1,8,15 and 22 of each cycle. Only on cycles 2 and 5,
following the administration of Bortezomib, dexamethasone 40mg iv and Rituximab 375 mg/m2 iv
will be administered. A total of 8 infusions of rituximab will be administered. Subsequently
patients rated as CR, PR, MR or SD will be followed without any treatment until there is
evidence of progressive disease.