drugset / Trial / NCT01125293
Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
Phase 1/2
Terminated
46 enrolled
Dana-Farber Cancer Institute
Millennium Pharmaceuticals, Inc. · collabNovartis · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.6 mg/m2 | Intravenous |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/kg | Intravenous |