NCT00573391

Study of Multiple Myeloma Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2

A Phase III Study for Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 (TT2, UARK 98-026): Bortezomib, Thalidomide and Dexamethasone Versus Bortezomib, Melphalan, and Dexamethasone

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

Detailed description

A new drug (bortezomib \[VelcadeTM PS-341\]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Velcade, Thalidomide, and Dexamethasone	Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles Thalidomide - By Mouth Days 1-28 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles
DRUG	Velcade, Melphalan, and Dexamethasone	Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-12-14
• Last updated: 2011-08-12
• Results posted: 2011-08-12

Locations

1 site across 1 country: United States