Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099047
Status:
COMPLETED
Last Update Posted:
2016-12-30
First Post:
2004-12-08
Brief Title:
Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Biologic and Clinical Role of COX-2 Inhibitor Celecoxibin the Management of MGUS and Smoldering Myeloma
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This randomized phase II trial studies how well celecoxib works in preventing multiple myeloma in patients with monoclonal gammopathy or smoldering myeloma Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of celecoxib may be effective in preventing multiple myeloma
Detailed Description:
PRIMARY OJBECTIVES
I Determine the efficacy of celecoxib vs placebo in reducing serum levels of M-component in patients with monoclonal gammopathy of undetermined significance or smoldering myeloma
SECONDARY OBJECTIVES
I Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these patients
OUTLINE
This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and type of monoclonal gammopathy monoclonal gammopathy of undetermined significance vs smoldering myeloma Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive celecoxib orally PO twice daily BID for 6 months in the absence of unacceptable toxicity or progression to malignancy
ARM II Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy
After completion of study treatment patients are followed at 1 6 and 12 months
I Determine the efficacy of celecoxib vs placebo in reducing serum levels of M-component in patients with monoclonal gammopathy of undetermined significance or smoldering myeloma
SECONDARY OBJECTIVES
I Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these patients
OUTLINE
This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and type of monoclonal gammopathy monoclonal gammopathy of undetermined significance vs smoldering myeloma Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive celecoxib orally PO twice daily BID for 6 months in the absence of unacceptable toxicity or progression to malignancy
ARM II Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy
After completion of study treatment patients are followed at 1 6 and 12 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CN25140 | OTHER | US NIH GrantContract Award Number | None |
| NCI-2009-00866 | REGISTRY | None | None |
| CDR0000393514 | None | None | None |
| UARK-18697 | None | None | None |
| MAYO-206904 | None | None | None |
| CCF-IRB-7029 | OTHER | None | None |
| N01-CN-25140 | OTHER | None | None |