Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone

Phase 3 Completed 502 enrolled Millennium Pharmaceuticals, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.

Timeline

Start: 2007-06
Primary completion: 2013-03
Completion: 2013-03

Publications

Niesvizky R, Flinn IW, Rifkin R, Gabrail N, Charu V, Clowney B, Essell J, Gaffar Y, Warr T, Neuwirth R, Zhu Y, Elliott J, Esseltine DL, Niculescu L, Reeves J. Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens. J Clin Oncol. 2015 Nov 20;33(33):3921-9. doi: 10.1200/JCO.2014.58.7618. Epub 2015 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	20 mg	Oral
Subject	Melphalan	Small molecule	9 mg/m2	Oral
Subject	Prednisone	Other / unclassified	60 mg/m2	Oral
Subject	Thalidomide	Other / unclassified	100 mg	Oral
Background	Bortezomib	Small molecule	1.6 mg/m2	Intravenous

Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone

Summary

Timeline

Publications

Drugs

Indications