drugset / Trial / NCT01788020

Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia

NCT01788020

RandomizedParallel-groupOpen-labelTreatment

Summary

In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without inducing major hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed substantial activity as a single agent in WM with only very few side effects when given in a weekly schedule. Based on these observations it is the aim of this study to test whether the efficacy of the well tolerated DRC regime can be further improved by adding Bortezomib.

Timeline

Start
2013-11
Primary completion
2018-11
Completion
2024-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.6 mg/m2 Subcutaneous
Comparator Cyclophosphamide Other / unclassified 100 mg/m2 Oral
Comparator Dexamethasone Small molecule 20 mg Oral
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Rituximab Monoclonal antibody 1400 mg Intravenous