Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084747
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2004-06-10
Brief Title:
Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase III Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2016-02
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:
RATIONALE Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission
PURPOSE This phase III trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma
PURPOSE This phase III trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma
Detailed Description:
OBJECTIVES
Determine response rate as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia in the first year after autologous peripheral blood stem cell transplantation in patients with intermediate or advanced multiple myeloma treated with adjuvant bortezomib
Compare progression-free survival of patients treated with adjuvant bortezomib with historical controls treated with autologous transplantation alone
Determine the toxicity of this drug in these patients phase I
OUTLINE This is a multicenter dose-escalation study
Patients receive bortezomib IV on days 1 8 and 15 Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 2 years
Determine response rate as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia in the first year after autologous peripheral blood stem cell transplantation in patients with intermediate or advanced multiple myeloma treated with adjuvant bortezomib
Compare progression-free survival of patients treated with adjuvant bortezomib with historical controls treated with autologous transplantation alone
Determine the toxicity of this drug in these patients phase I
OUTLINE This is a multicenter dose-escalation study
Patients receive bortezomib IV on days 1 8 and 15 Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| MILLENNIUM-MM2003 | None | None | None |
| UCLA-0306106 | None | None | None |