Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263484
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2005-12-07
Brief Title:
Higher Frequency Zoledronic Acid in the Treatment of Multiple Myeloma
Sponsor:
Gleneagles Hospital
Organization:
Gleneagles Hospital
Study Overview
Official Title:
An International Multicenter Non-Randomized Open-Labeled Study to Evaluate the Efficacy of Lower Dose DexamethasoneThalidomide and Higher Frequency ZOMETATM in the Treatment of Previously Untreated Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-07
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:
dtZ
Brief Summary:
The purpose of this study is to determine whether lower than conventional doses of dexamethasone and thalidomide and a higher dosing frequency of zoledronic acid are effective in the treatment of newly-diagnosed multiple myeloma
Detailed Description:
Patients with newly-diagnosed multiple myeloma MM may be treated using monthly cycles of dexamethasone plus thalidomide DT Unfortunately the use of conventional doses of DT is associated with significant treatment-related morbidity and mortality which is comparable to that observed with conventional chemotherapy Hence for safety reasons patients frequently receive lower than conventional doses of DT ie dt and potentially experience a poorer anti-MM effect The highly-potent aminobisphosphonate zoledronic acid Z has been shown in pre-clinical mouse models to exhibit an impressive anti-MM effect It is therefore possible to combined dt with Z ie dtZ to enhance the efficacy of lower dose dt In addition the anti-tumor effect of dtZ may potentially be augmented by using Z at a higher three-weekly dosing frequency
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