Bortezomib, Dexamethasone, and Rituximab in Untreated Waldenstroms Macroglobulinemia

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2013

Conditions
Waldenstroms Macroglobulinemia
Interventions
DRUG

Bortezomib, Dexamethasone, Rituximab

The 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.

Trial Locations (1)

Unknown

University of Athens School of Medicine, Athens

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Athens

OTHER

collaborator

University of Roma La Sapienza

OTHER

collaborator

Niguarda Hospital

OTHER

collaborator

University of Turin, Italy

OTHER

collaborator

University of Salamanca

OTHER

collaborator

Hospital Clinic of Barcelona

OTHER

collaborator

Hotel Dieu Hospital

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

University Hospital, Toulouse

OTHER

collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

collaborator

Laikο General Hospital, Athens

OTHER

collaborator

Klinikum der Universitaet Muenchen, Grosshadern

OTHER

collaborator

Aalborg University Hospital

OTHER

collaborator

Centre Hospitalier de Lens

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

Theagenio Cancer Hospital

OTHER_GOV

collaborator

University of Wuerzburg

OTHER

collaborator

Skane University Hospital

OTHER

collaborator

Sahlgrenska University Hospital

OTHER

lead

European Myeloma Network B.V.

NETWORK