Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093028
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2004-09-29
Brief Title:
Study of Bortezomib and Revlimid for Patients Relapsing or Progressing on Total Therapy II
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
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
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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 patients 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
BORTEZOMIB alone
BORTEZOMIB REVLIMID
BORTEZOMIB in a lower dose REVLIMID
This chance selection process is called randomization and is often used in research studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None