Bortezomib, Dexamethasone, and Rituximab in Untreated Waldenstroms Macroglobulinemia
- Sponsor
- European Myeloma Network B.V.
- Study ID
- NCT00832234
- Phase
- PHASE2
- Status
- Completed
Conditions
- Waldenstroms Macroglobulinemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bortezomib, Dexamethasone, Rituximab — DRUGThe combination of bortezomib, dexamethasone and rituximab will be administered in five treatment cycles. 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 one. 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 375mg/m2 IV will be administered. A total of 8 infusions of rituximab will be administered. The administration of bortezomib before rituximab may abrogate the IgM flare phenomenon that occurs frequently after the first course of rituximab.
Study Details
This is a Phase II multicenter study designed to evaluate the safety and efficacy of combination BDR. BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM.
Key Dates
- Start date
- Sep 30, 2006
- Status verified
- Feb 2015
- Primary completion
- Jun 30, 2010
- Completion
- Jun 30, 2013
Study Design
- Enrollment
- 59 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: BDR
Primary Outcome Measure
The response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM. [ Time Frame: Two years ]