Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334932
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2006-06-07
Brief Title:
Doxorubicin Hydrochloride Liposome Melphalan and Bortezomib in Treating Patients With Relapsed or Refractory Stage I Stage II or Stage III Multiple Myeloma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Liposomal Doxorubicin Doxil MelphalanBortezomib Velcade in RelapsedRefractory Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
RECRUITING
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 Drugs used in chemotherapy such as doxorubicin hydrochloride liposome and melphalan work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving doxorubicin hydrochloride liposome and melphalan together with bortezomib may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of doxorubicin hydrochloride liposome melphalan and bortezomib and to see how well they work in treating patients with relapsed or refractory stage I stage II or stage III multiple myeloma
PURPOSE This phase III trial is studying the side effects and best dose of doxorubicin hydrochloride liposome melphalan and bortezomib and to see how well they work in treating patients with relapsed or refractory stage I stage II or stage III multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of doxorubicin HCl liposome melphalan and bortezomib in patients with relapsed or refractory stage I-III multiple myeloma
Determine the maximum tolerated dose MTD of this regimen in these patients
Secondary
Determine the overall response rate including complete near-complete partial and minimal response rate in patients treated with this regimen
Determine the time to response progression-free survival and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen at the MTD in these patients
OUTLINE This is a multicenter phase I dose-escalation study followed by a phase II study
Phase I Patients receive doxorubicin HCl liposome IV over 30-60 minutes and melphalan IV over 30 minutes on day 1 and bortezomib IV on days 1 4 8 and 11 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome melphalan and bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 4 of 6 patients experience dose-limiting toxicity after 2 courses of therapy
Phase II Patients receive doxorubicin HCl liposome melphalan and bortezomib at the MTD as in phase I
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL Approximately 32 patients will be accrued for this study
Primary
Determine the safety and tolerability of doxorubicin HCl liposome melphalan and bortezomib in patients with relapsed or refractory stage I-III multiple myeloma
Determine the maximum tolerated dose MTD of this regimen in these patients
Secondary
Determine the overall response rate including complete near-complete partial and minimal response rate in patients treated with this regimen
Determine the time to response progression-free survival and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen at the MTD in these patients
OUTLINE This is a multicenter phase I dose-escalation study followed by a phase II study
Phase I Patients receive doxorubicin HCl liposome IV over 30-60 minutes and melphalan IV over 30 minutes on day 1 and bortezomib IV on days 1 4 8 and 11 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome melphalan and bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 4 of 6 patients experience dose-limiting toxicity after 2 courses of therapy
Phase II Patients receive doxorubicin HCl liposome melphalan and bortezomib at the MTD as in phase I
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL Approximately 32 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-AAAB6443 | None | None | None |