Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066638
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2003-08-06
Brief Title:
FR901228 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 2 Study of Depsipeptide in RelapsedRefractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and efficacy of depsipeptide in patients with refractory or relapsed multiple myeloma MM
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a stable plateau stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart may receive maintenance therapy comprising FR901228 IV on days 1 and 15 with courses repeating every 28 days
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study within 5-125 months
I To evaluate the safety and efficacy of depsipeptide in patients with refractory or relapsed multiple myeloma MM
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a stable plateau stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart may receive maintenance therapy comprising FR901228 IV on days 1 and 15 with courses repeating every 28 days
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study within 5-125 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 |
|---|---|---|---|
| P30CA013330 | NIH | CTEP | httpsreporternihgovquickSearchP30CA013330 |
| NCI-2012-03005 | REGISTRY | None | None |
| NCI-5996 | None | None | None |
| 0403-765 | OTHER | None | None |
| 5996 | OTHER | None | None |
| N01CM62204 | NIH | None | None |