Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008242
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2001-01-06
Brief Title:
Thalidomide Doxorubicin and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Clinical Trial Of Thalidomide Adramycin And Dexamethasone TAD As Initial Therapy For The Treatment Of Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-03
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:
RATIONALE Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the cancer cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining thalidomide with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of thalidomide doxorubicin and dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma
PURPOSE Phase II trial to study the effectiveness of thalidomide doxorubicin and dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma
Detailed Description:
OBJECTIVES I Determine the response rate of patients with previously untreated stage II or III multiple myeloma treated with thalidomide doxorubicin and dexamethasone II Determine the safety and toxicity of this regimen in this patient population
OUTLINE Patients receive oral dexamethasone on days 1-4 9-12 and 17-20 doxorubicin IV on day 1 and oral thalidomide daily Treatment repeats every 30 days for 4 courses in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within approximately 1 year
OUTLINE Patients receive oral dexamethasone on days 1-4 9-12 and 17-20 doxorubicin IV on day 1 and oral thalidomide daily Treatment repeats every 30 days for 4 courses in the absence of unacceptable toxicity or disease progression
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within approximately 1 year
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 |
|---|---|---|---|
| NCI-G00-1893 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-00077 | None | None | None |