Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113919
Status:
TERMINATED
Last Update Posted:
2017-10-16
First Post:
2005-06-10
Brief Title:
UARK 2003-25 A Study of Intravenous IV Busulfan Busulfex in Multiple Myeloma Patients
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
UARK 2003-25 A Phase III Open Label Study of IV Busulfan Busulfex in Multiple Myeloma Patients Older Than 65 Years of Age or With Renal Insufficiency
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to poor accrual
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 if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex followed by autologous transplant compared to treatment with the standard drug called melphalan which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses
Detailed Description:
This trial will determine the maximal dose of Busulfex that can be given in a two three or four day period with acceptable toxicity to myeloma patients who either are or 65 years of age or have renal insufficiency defined as creatinine 3gdL or creatinine clearance 30 mlmin
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