Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047203
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2002-10-03
Brief Title:
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate in patients with relapsed or refractory multiple myeloma treated with flavopiridol
II Determine the disease-free survival and overall survival of patients treated with this drug
III Correlate disease response with t1114q13q32 rearrangement p16 methylation status and BCRP expression in patients treated with this drug
IV Correlate disease response and drug treatment with cell cycle status and effects on apoptosis and apoptosis regulatory proteins in these patients
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity After 12 months patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 1 year
I Determine the response rate in patients with relapsed or refractory multiple myeloma treated with flavopiridol
II Determine the disease-free survival and overall survival of patients treated with this drug
III Correlate disease response with t1114q13q32 rearrangement p16 methylation status and BCRP expression in patients treated with this drug
IV Correlate disease response and drug treatment with cell cycle status and effects on apoptosis and apoptosis regulatory proteins in these patients
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity After 12 months patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 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 |
|---|---|---|---|
| MC018B | None | None | None |
| N01CM17104 | NIH | None | None |
| CDR0000257567 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17104 |