Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

Phase 2 Completed 55 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.

Timeline

Start: 2008-09
Primary completion: 2011-02
Completion: 2011-03

Publications

Craig M, Hanna WT, Cabanillas F, Chen CS, Esseltine DL, Neuwirth R, O'Connor OA. Phase II study of bortezomib in combination with rituximab, cyclophosphamide and prednisone with or without doxorubicin followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma. Br J Haematol. 2014 Sep;166(6):920-8. doi: 10.1111/bjh.12991. Epub 2014 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.6 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	1000 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Subject	Prednisone	Other / unclassified	100 mg	Oral
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

Summary

Timeline

Publications

Drugs

Indications