drugset / Trial / NCT00832234
Bortezomib, Dexamethasone, and Rituximab in Untreated Waldenstroms Macroglobulinemia
Phase 2
Completed
59 enrolled
European Myeloma Network B.V.
Aalborg University Hospital · collabCentre Hospitalier de Lens · collabErasmus Medical Center · collabFondazione IRCCS Policlinico San Matteo di Pavia · collabHospital Clinic of Barcelona · collabHotel Dieu Hospital · collabKlinikum der Universitaet Muenchen, Grosshadern · collabLaikο General Hospital, Athens · collabNiguarda Hospital · collabSahlgrenska University Hospital · collabSkane University Hospital · collabTheagenio Cancer Hospital · collabUniversitaire Ziekenhuizen KU Leuven · collabUniversity Hospital, Toulouse · collabUniversity of Athens · collabUniversity of Roma La Sapienza · collabUniversity of Salamanca · collabUniversity of Turin, Italy · collabUniversity of Wuerzburg · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2010-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.6 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |