drugset / Trial / NCT01125293

Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

NCT01125293

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to test the safety of the combination of everolimus, rituximab and bortezomib. Everolimus is a drug that works by preventing cells in your body from growing and dividing. Information from basic and other clinical research suggests that everolimus may also inhibit tumor growth in people with relapsed or refractory lymphoma. The FDA has approved everolimus for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's Macroglobulinemia. Rituximab is approved by the FDA for the treatment of non-Hodgkin's lymphoma, which included Waldenstrom's Macroglobulinemia. Funding Source - FDA OOPD

Timeline

Start
2010-04
Primary completion
2013-12
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.6 mg/m2 Intravenous
Subject Everolimus Small molecule 10 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/kg Intravenous