NCT00507416

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

Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE, Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib bolus intravenous (IV) injection
DRUG	Dexamethasone	Dexamethasone for oral administration
DRUG	Melphalan	Melphalan for oral administration
DRUG	Prednisone	Prednisone for oral administration
DRUG	Thalidomide	Thalidomide for oral administration

Timeline

• Start date: 2007-06-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2007-07-26
• Last updated: 2014-05-01
• Results posted: 2014-05-01

Locations

235 sites across 2 countries: United States, Puerto Rico