Phase II Study of Combination Therapy with bortezomib and rituximab in patients with relapsed/refractory Waldenstrom’s macroglobulinemia.
Sponsor: Millenium Pharmaceuticals
Institution: Dana-Farber Cancer Institute
Physician: Irene Ghobrial, MD
The goal of this study is to find out if the combination of bortezomib and rituximab is effective in treating Waldenstrom’s macroglobulinemia. In this study, subjects will receive two drugs. The first drug is bortezomib by injection, commonly known as VELCADE® for Injection, which is administered by intravenous injection. Bortezomib has received FDA approval for the treatment of multiple myeloma in patients who have received at least one prior therapy. Bortezomib is still currently under investigation for other indications. Bortezomib has not been approved by the FDA for WM. The FDA has approved bortezomib for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom’s macroglobulinemia.
The second drug is rituximab (commonly known as Rituxan or Mabthera), a monoclonal antibody. This drug can bind to Waldenstrom’s tumor cells, which may allow the immune system to kill the tumor cells. Rituximab is approved by the FDA for the treatment of non-Hodgkins Lymphoma, which includes Waldenstrom’s macroglobulinemia.
The combination of these two drugs has not been studied for patients with relapsed/refractory WM. It is currently being studied as first line therapy for WM. Therefore, this combination is considered investigational.
Subjects will receive 6 cycles of treatment with bortezomib and rituximab. Each cycle is 28 days long. Bortezomib will be given once a week for the first three weeks per cycle, followed by 1 week of rest. Rituximab will be given once a week, all four weeks of the cycle, but only in cycles one and four. The first 6 cycles will be given one after the other. Three months after completing the sixth cycle of therapy, you will receive one dose of therapy with bortezomib and rituximab every three months for a total of two years. We anticipate that subjects will complete their treatment within 6 months.