Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389701
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2006-10-18
Brief Title:
Bortezomib and Dexamethasone in Treating Patients With Multiple Myeloma That Has Relapsed or Has Not Responded to Treatment
Sponsor:
Sparrow Regional Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Twice Weekly Induction Followed by Once Weekly IV Velcade Bortezomib With Dexamethasone in Patients With Relapsed andor Refractory Multiple Myeloma Following at Least 1 Prior Therapy
Status:
UNKNOWN
Status Verified Date:
2009-06
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 Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and 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 dexamethasone may kill more cancer cells
PURPOSE This phase II trial is studying how well giving bortezomib together with dexamethasone works in treating patients with multiple myeloma that has relapsed or has not responded to treatment
PURPOSE This phase II trial is studying how well giving bortezomib together with dexamethasone works in treating patients with multiple myeloma that has relapsed or has not responded to treatment
Detailed Description:
OBJECTIVES
Primary
Determine the overall response rate complete response and partial response in patients with relapsed or refractory multiple myeloma treated with induction therapy and maintenance therapy comprising bortezomib and dexamethasone
Secondary
Determine the toxicity of this regimen in these patients
Determine the tolerability of this regimen in these patients
Determine the duration of response in patients treated with this regimen
Determine time to progression in patients treated with this regimen
Determine overall and progression-free survival of patients treated with this regimen
OUTLINE This is an open-label study
Induction therapy Patients receive bortezomib IV on days 1 4 8 and 11 Patients also receive oral dexamethasone on days 1 2 4 5 8 9 11 and 12 Treatment repeats every 21 days for 4 courses Patients who achieve complete response CR receive an additional 2 courses of induction therapy and proceed to maintenance therapy
Maintenance therapy Patients receive bortezomib IV on days 1 8 15 and 22 Patients also receive oral dexamethasone on days 1 2 8 9 15 16 22 and 23 Treatment repeats every 36 days in the absence of disease progression or unacceptable toxicity Patients who achieve CR receive an additional 2 courses of maintenance therapy beyond documentation of CR
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the overall response rate complete response and partial response in patients with relapsed or refractory multiple myeloma treated with induction therapy and maintenance therapy comprising bortezomib and dexamethasone
Secondary
Determine the toxicity of this regimen in these patients
Determine the tolerability of this regimen in these patients
Determine the duration of response in patients treated with this regimen
Determine time to progression in patients treated with this regimen
Determine overall and progression-free survival of patients treated with this regimen
OUTLINE This is an open-label study
Induction therapy Patients receive bortezomib IV on days 1 4 8 and 11 Patients also receive oral dexamethasone on days 1 2 4 5 8 9 11 and 12 Treatment repeats every 21 days for 4 courses Patients who achieve complete response CR receive an additional 2 courses of induction therapy and proceed to maintenance therapy
Maintenance therapy Patients receive bortezomib IV on days 1 8 15 and 22 Patients also receive oral dexamethasone on days 1 2 8 9 15 16 22 and 23 Treatment repeats every 36 days in the absence of disease progression or unacceptable toxicity Patients who achieve CR receive an additional 2 courses of maintenance therapy beyond documentation of CR
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| SPARROW-IRB-6016 | None | None | None |
| SPARROW-I071-341-03 | None | None | None |