Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124579
Status:
TERMINATED
Last Update Posted:
2018-08-09
First Post:
2005-07-26
Brief Title:
S0417 Bortezomib Thalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0417 A Phase II Study of Bortezomib Velcade PS-341 Thalidomide and Dexamethasone in Patients With Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 some of the enzymes needed for cell growth Biological therapies such as thalidomide may stimulate the immune system in different ways and stop cancer cells from growing It may also stop the growth of cancer by blocking blood flow to the cancer Drugs used in chemotherapy such as dexamethasone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells
PURPOSE This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma
PURPOSE This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Determine the confirmed overall response rate complete remission remission and partial remission in patients with relapsed or refractory multiple myeloma treated with bortezomib thalidomide and dexamethasone
Determine overall and progression-free survival of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Correlate preliminarily treatment with bortezomib with the activation of osteoblasts in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive bortezomib IV on days 1 4 8 and 11 oral thalidomide once daily on days 1-21 and oral dexamethasone once daily on days 1 2 4 5 8 9 11 and 12 Treatment repeats every 21 days until achievement of confirmed complete remission CR remission R or partial remission PR OR for up to 8 courses in the absence of disease progression or unacceptable toxicity
Patients achieving confirmed CR R or PR who reach a plateau prior to receiving the maximum 8 courses of induction therapy OR who achieve confirmed CR R or PR after receiving the maximum 8 courses of induction therapy proceed to maintenance therapy Patients achieving stable disease after receiving the maximum 8 courses of induction therapy either proceed to maintenance therapy or receive further treatment with bortezomib thalidomide and dexamethasone off-study
Maintenance therapy Patients receive oral dexamethasone on days 1-4 Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed within 30 days and then every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 18 months
Determine the confirmed overall response rate complete remission remission and partial remission in patients with relapsed or refractory multiple myeloma treated with bortezomib thalidomide and dexamethasone
Determine overall and progression-free survival of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Correlate preliminarily treatment with bortezomib with the activation of osteoblasts in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive bortezomib IV on days 1 4 8 and 11 oral thalidomide once daily on days 1-21 and oral dexamethasone once daily on days 1 2 4 5 8 9 11 and 12 Treatment repeats every 21 days until achievement of confirmed complete remission CR remission R or partial remission PR OR for up to 8 courses in the absence of disease progression or unacceptable toxicity
Patients achieving confirmed CR R or PR who reach a plateau prior to receiving the maximum 8 courses of induction therapy OR who achieve confirmed CR R or PR after receiving the maximum 8 courses of induction therapy proceed to maintenance therapy Patients achieving stable disease after receiving the maximum 8 courses of induction therapy either proceed to maintenance therapy or receive further treatment with bortezomib thalidomide and dexamethasone off-study
Maintenance therapy Patients receive oral dexamethasone on days 1-4 Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed within 30 days and then every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0417 | OTHER | None | None |