Phase II Clinical Trial of combination therapy with bortezomib, dexamethasone, and rituximab in patients with WM
Sponsor: Millenium Pharmaceuticals
Institution: Dana-Farber Cancer Institute
Physician: Steven P. Treon, MD, MA, PhD
This clinical trial will assess if the combination of bortezomib, dexamethasone and rituximab is effective at treating WM.This trial is for patients with untreated WM. Bortezomib and dexamethasone have received FDA approval for treatment of other types of cancer, but have not been approved for the treatment of WM. Rituximab has been FDA approved for treatment of non-Hodgkin's lymphoma, which includes WM. The combination of these drugs in WM is considered investigational.
Patients eligible for this study will receive 8 cycles of combination therapy, each 21 days long. Therapy will be given on the first, fourth, eighth and eleventh days of each cycle, followed by 10 days of rest. The first 4 cycles will be given consecutively. Three months after completion of the initial 4 cycles, patients will receive treatment cycles every three months. Therapy will be completed over a period of 15 months. On the first, fourth, eighth and eleventh days of each cycle, patients recieve bortezomib and dexamethasone intravenously. On the eleventh day, patients will also receive rituximab intravenously. Therapy will continue provided the patient experiences no serious side effects or the disease does not progress.