Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075881
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2004-01-09
Brief Title:
Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of PS-341 for Patients With High-Risk Newly Diagnosed Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2014-03
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 phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response rate to PS-341 bortezomib induction in patients with high risk newly diagnosed multiple myeloma
SECONDARY OBJECTIVES
I To evaluate progression free survival II To explore the response rate of patients who relapse or progress on maintenance and then return to induction schedule
III To explore duration of second response
TERTIARY OBJECTIVES
I To explore a possible differential response to PS-341 with previously described adverse prognostic indicators
II To explore specific gene expression profiles GEP that may predict response to therapy to an agent or combination of agents used in the treatment of newly diagnosed myeloma
III To explore specific post-treatment gene expression profiles GEP in the patients who have received 4 cycles of therapy and achieved a minimal response or better
IV To develop relevant information about the immune system for multiple myeloma patients treated with PS-341
OUTLINE
INDUCTION TREATMENT Patients receive bortezomib intravenously IV on days 1 4 8 and 11 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
MAINTENANCE TREATMENT Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
REINDUCTION TREATMENT Patients who progress while on maintenance treatment receive bortezomib IV on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 4 years
I To evaluate the response rate to PS-341 bortezomib induction in patients with high risk newly diagnosed multiple myeloma
SECONDARY OBJECTIVES
I To evaluate progression free survival II To explore the response rate of patients who relapse or progress on maintenance and then return to induction schedule
III To explore duration of second response
TERTIARY OBJECTIVES
I To explore a possible differential response to PS-341 with previously described adverse prognostic indicators
II To explore specific gene expression profiles GEP that may predict response to therapy to an agent or combination of agents used in the treatment of newly diagnosed myeloma
III To explore specific post-treatment gene expression profiles GEP in the patients who have received 4 cycles of therapy and achieved a minimal response or better
IV To develop relevant information about the immune system for multiple myeloma patients treated with PS-341
OUTLINE
INDUCTION TREATMENT Patients receive bortezomib intravenously IV on days 1 4 8 and 11 Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
MAINTENANCE TREATMENT Patients who complete induction treatment without progressive disease receive bortezomib IV on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
REINDUCTION TREATMENT Patients who progress while on maintenance treatment receive bortezomib IV on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 4 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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2014-00652 | REGISTRY | None | None |
| CDR0000349450 | None | None | None |
| E2A02 | OTHER | None | None |
| E2A02 | OTHER | None | None |