A Multicenter Phase II Study of Ofatumumab and Bortezomib (OB) in Previously Untreated Patients with Waldenström Macroglobulinemia
For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or email Amelyn at email@example.com.
- Men and women age 18 and older
- Diagnosis of Waldenstrom Macroglobulinemia (WM)
- No prior anti-neoplastic therapy for WM
- Detailed eligibility reviewed when you contact the study team
Although there is currently no standard treatment for first-line management of WM, most clinicians and investigators believe that anti-CD20 directed therapy should compromise part of the regimen. Because it was the first therapeutic monoclonal antibody approved by the FDA , rituximab has been evaluated more than any antibody and has shown modest effects with limited toxicity. However, new treatments for WM are needed.
Ofatumumab has been approved for treatment of relapsed/refractory Chronic Lymphocytic Leukemia (CLL). It is an anti-CD20 monoclonal antibody that compared favorably to rituximab in a recent Phase 2 trial in patients with WM.
The purpose of the study is to determine how well previously untreated people with Waldenstrom Macroglobulinemia respond to treatment with ofatumumab in combination with bortezomib (Velcade). The study will also evaluate the safety of ofatumumab in combination with bortezomib.
Study participants will have four 28-day cycles of induction phase therapy. Participants will receive treatments weekly for three weeks, and then have a rest period (no treatment) for the fourth week. After the four cycles, there will be 4 weeks of no therapy and then 4 cycles of maintenance phase therapy. The maintenance cycles will be 28 days long. Participants will receive three weeks of treatment, then a resting period (no treatment) for the fourth week. This will be followed by four weeks of rest (no treatments). Then a new cycle will begin. Thus a new cycle of maintenance treatment will begin every 8 weeks. The entire period for both induction and maintenance therapy will be 1 year (52 weeks).
Participants will be followed until disease progression or 5 years from study entry, whichever comes first.