Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401011
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2006-11-15
Brief Title:
Safety Efficacy Study of Perifosine Bortezomib - Dexamethasone for Multiple Myeloma Patients
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
An Open-Label Phase III Study of the Safety and Efficacy of Perifosine and Bortezomib With or Without Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Bortezomib
Status:
COMPLETED
Status Verified Date:
2012-02
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 III study of perifosine in combination with bortezomib-with or without dexamethasone-for patients with relapsed or refractory multiple myeloma previously treated with bortezomib The current protocol will enroll patients with relapsed or refractory multiple myeloma who have been previously treated with bortezomib The patients will be treated with perifosine 50 mg or 100 mg qhs in combination with bortezomib to determine if there is any preliminary evidence that the addition of perifosine improves the outcome for these patients Previous treatment with perifosine will be allowed in this study Patients progressing on treatment with perifosine and bortezomib will receive dexamethasone 20 mg on days 1 2 4 5 8 9 11 12 15 16 18 and 19 of each 21-day cycle in addition to bortezomib and perifosine
Detailed Description:
The primary objective of the phase I portion is to determine the maximum tolerated dose of perifosine in combination with bortezomib in patients previously treated with bortezomib
All patients will receive daily perifosine qhs with food In the initial phase I study 3 patients will be entered into a specified combination of perifosine and bortezomib cohorts If no dose-limiting toxicity is observed then three additional patients will be entered in cohort 4 - a full dose of bortezomib 13 mgm2 on days 1 4 8 and 11 every 3 weeks If this dose is tolerated it will be used for the phase II study otherwise an intermediate dose of 1 mgm2 on days 1 4 8 and 11 every 3 weeks will be employed
The phase II study will use the maximum tolerated dose of bortezomib and perifosine The primary objective of phase II portion is to determine the response rate the combined CR PR MR following treatment with perifosine bortezomib in patients with multiple myeloma who have relapsed following initial front-line therapy are refractory to their most recent therapy and were previously treated with bortezomib The secondary objectives of the phase II portion are
1 To further assess the safety and tolerability of perifosine in combination with bortezomib-with or without dexamethasone-in patients with multiple myeloma
2 To obtain correlative data in patients with multiple myeloma treated with perifosine in combination with bortezomib-with or without dexamethasone NOTE Centers may choose not to participate in correlative studies
All patients will receive daily perifosine qhs with food In the initial phase I study 3 patients will be entered into a specified combination of perifosine and bortezomib cohorts If no dose-limiting toxicity is observed then three additional patients will be entered in cohort 4 - a full dose of bortezomib 13 mgm2 on days 1 4 8 and 11 every 3 weeks If this dose is tolerated it will be used for the phase II study otherwise an intermediate dose of 1 mgm2 on days 1 4 8 and 11 every 3 weeks will be employed
The phase II study will use the maximum tolerated dose of bortezomib and perifosine The primary objective of phase II portion is to determine the response rate the combined CR PR MR following treatment with perifosine bortezomib in patients with multiple myeloma who have relapsed following initial front-line therapy are refractory to their most recent therapy and were previously treated with bortezomib The secondary objectives of the phase II portion are
1 To further assess the safety and tolerability of perifosine in combination with bortezomib-with or without dexamethasone-in patients with multiple myeloma
2 To obtain correlative data in patients with multiple myeloma treated with perifosine in combination with bortezomib-with or without dexamethasone NOTE Centers may choose not to participate in correlative studies
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