Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253578
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2005-11-11
Brief Title:
Sorafenib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of BAY 43-9006 Sorafenib NSC-724772 in Patients With Relapsing or Resistant Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-01
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 is studying how well sorafenib works in treating patients with relapsed or refractory multiple myeloma Sorafenib 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
Detailed Description:
PRIMARY OBJECTIVES
I To assess the overall response rate confirmed CR R and PR in patients with relapsedrefractory multiple myeloma treated with BAY 43-9006
II To evaluate qualitative and quantitative toxicities associated with this regimen
III To assess overall and progression-free survival in this group of patients treated with this regimen
IV To explore in a preliminary manner associations between gene expression signatures and response
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 3 years
I To assess the overall response rate confirmed CR R and PR in patients with relapsedrefractory multiple myeloma treated with BAY 43-9006
II To evaluate qualitative and quantitative toxicities associated with this regimen
III To assess overall and progression-free survival in this group of patients treated with this regimen
IV To explore in a preliminary manner associations between gene expression signatures and response
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 3 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 |
|---|---|---|---|
| CDR0000449973 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0434 | None | None | None |
| U10CA032102 | NIH | None | None |