Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415064
Status:
COMPLETED
Last Update Posted:
2012-07-06
First Post:
2006-12-20
Brief Title:
Phase I Study of Perifosine Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
An Open-Label Phase I Study of the Safety of Perifosine in Combination With Lenalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-11
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 is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma The current protocol will enroll patients with relapsed or refractory multiple myeloma requiring second or third line therapy Six patients each will be treated with at one of 4 dose levels in a phase 1 study All patients will receive perifosine lenalidomide and dexamethasone of each 28 day cycle The doses of perifosine and lenalidomide will be varied in each group The dose of dexamethasone will remain constant
Detailed Description:
This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma All patients will receive lenalidomide daily for days 1 to 21 of each 28 day cycle Perifosine will be given daily qhs with food Dexamethasone will be given on days 1-4 9-12 and 17-20 for 4 cycles After 4 cycles dexamethasone will be given only on days 1-4 Four dose levels will be studied
1 Perifosine 50 mg lenalidomide 15 mg and dexamethasone 20 mg
2 Perifosine 50 mg lenalidomide 25 mg and dexamethasone 20 mg
3 Perifosine 100 mg lenalidomide 15 mg and dexamethasone 20 mg
4 Perifosine 100 mg lenalidomide 25 mg and dexamethasone 20 mg
Six patients will be enrolled at each dose level until the maximum tolerated dose MTD is reached Six additional patients will be treated at the MTD
1 Perifosine 50 mg lenalidomide 15 mg and dexamethasone 20 mg
2 Perifosine 50 mg lenalidomide 25 mg and dexamethasone 20 mg
3 Perifosine 100 mg lenalidomide 15 mg and dexamethasone 20 mg
4 Perifosine 100 mg lenalidomide 25 mg and dexamethasone 20 mg
Six patients will be enrolled at each dose level until the maximum tolerated dose MTD is reached Six additional patients will be treated at the MTD
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