NCT00093028

Study of Bortezomib and Revlimid™ for Patients Relapsing or Progressing on Total Therapy II

UARK 2003-35, A Phase III Study of Bortezomib Versus Bortezomib in Two Doses in Combination With Revlimid™ for Patients Relapsing or Progressing on Total Therapy II (UARK 98-026)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is * to find out the effects of treating patients with two new chemotherapy drugs (bortezomib and Revlimid™), * to study how many patients' myeloma responds to treatment on this study, and how many patients survive after this treatment, * to learn if a patient's genetic makeup before and after treatment can predict which patients will respond to bortezomib and Revlimid™, and to learn more about how the body responds (gene array studies).

Detailed description

Two new drugs BORTEZOMIB (Velcade®, PS-341) and REVLIMID (CC-5013) have been shown in recent studies to be effective in patients with advanced multiple myeloma. This study is being done to learn more about the best way to administer these drugs, either alone or in combination. Since it is not known at this time which treatment is the best, participants will be placed by chance in one of the three treatment groups: * BORTEZOMIB alone * BORTEZOMIB + REVLIMID * BORTEZOMIB in a lower dose + REVLIMID. This chance selection process is called randomization and is often used in research studies.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	CC-5013 (Revlimid™)	N/A Study Complete
DRUG	bortezomib	N/A Study Complete

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2004-10-01
• Last updated: 2010-07-02

Locations

1 site across 1 country: United States