Efficacy of First Line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for Patients With Waldenström's Macroglobulinemia

NCT01788020 Phase 3 COMPLETED

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.

Details

Lead sponsor	University of Ulm
Phase	Phase 3
Status	COMPLETED
Enrolment	202
Start date	2013-11
Completion	2024-04

Conditions

• Waldenström's Macroglobulinemia

Interventions

• Dexamethasone, Rituximab, Cyclophosphamide
• Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib

Primary outcomes

• Progression Free Survival — participants will be followed for their participation in the trial, an expected average of 5.5 years
  PFS will be calculated from the date of inclusion/randomisation to the following events: the date of progression and the date of death if it occurred earlier. In the absence of progression and death, PFS duration will be censored at the stopping date or the date of last follow-up.

Countries

Germany