Bortezomib, Dexamethasone, and Rituximab in Untreated Waldenstroms Macroglobulinemia

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.

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.

Sponsors & Collaborators

• University of Athens

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• Niguarda Hospital

  collaborator OTHER

• University of Turin, Italy

  collaborator OTHER

• University of Salamanca

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hotel Dieu Hospital

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Laikο General Hospital, Athens

  collaborator OTHER

• Klinikum der Universitaet Muenchen, Grosshadern

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Centre Hospitalier de Lens

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Theagenio Cancer Hospital

  collaborator OTHER_GOV

• University of Wuerzburg

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• European Myeloma Network B.V.

  lead NETWORK

Principal Investigators

• Meletios A Dimopoulos, MD · University of Athens School of Medicine, Alexandra Hospital, Athens, Greece

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2010-06-30

Completion

2013-06-30

Countries

• Greece

Study Locations