Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083902
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2004-06-03
Brief Title:
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
UARK 98-025 A Randomized Phase II Trial of Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy for Low-Risk Post Transplantation Relapse in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a standard regimen of dexamethasone with or without thalidomide and also find out what kind of side effects patients will experience
Detailed Description:
Maintenance
Dexamethasone
Patients will receive 40 mg dexamethasone days 1-4 only every 3-4 weeks Response will be assessed at least every 3 months while on maintenance therapy Appropriate H2 blocker and antibiotics will also be given
Thalidomide
Thalidomide will continue at a dose of 400 mg daily or at the dose that was reduced and judged to be well tolerated in induction therapy Thalidomide will be given as an oral once daily dose at bedtime Those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met
Dexamethasone
Patients will receive 40 mg dexamethasone days 1-4 only every 3-4 weeks Response will be assessed at least every 3 months while on maintenance therapy Appropriate H2 blocker and antibiotics will also be given
Thalidomide
Thalidomide will continue at a dose of 400 mg daily or at the dose that was reduced and judged to be well tolerated in induction therapy Thalidomide will be given as an oral once daily dose at bedtime Those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met
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