drugset / Trial / NCT01470196

Carfilzomib, Rituximab and Dexamethasone in Waldenstrom's Macroglobulinemia

NCT01470196

Phase 2 Completed 31 enrolled Dana-Farber Cancer Institute Amgen · collab
NaSingle-groupOpen-labelTreatment

Summary

Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within the cell, which is responsible for degrading or breaking down a wide variety of proteins. Carfilzomib has not been approved by the FDA. Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM), alone or in combination with other drugs. Combinations with rituximab, dexamethasone and proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients. In this research study, the investigators are testing the safety and efficacy of Carfilzomib when used along with Rituximab and Dexamethasone as a possible treatment for Waldenstrom's Macroglobulinemia.

Timeline

Start
2011-10
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfilzomib Other / unclassified 36 mg/m2 Intravenous
Background Dexamethasone Small molecule 20 mg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous