Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482495
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
2007-06-04
Brief Title:
Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-05
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 Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Bevacizumab may also stop the growth of multiple myeloma by blocking blood flow to the cancer
PURPOSE This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory multiple myeloma
PURPOSE This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Primary
Determine the hematologic response rate in patients with relapsed or refractory multiple myeloma treated with bevacizumab
Determine the proportion of patients who are progression free and have not failed treatment after 1 year
Secondary
Determine the toxicity of this drug in these patient
Determine the time to disease progression in patients receiving this drug
Determine the overall survival and survival at 1 year in patients receiving this drug
OUTLINE This is an open-label study
Patients receive bevacizumab IV on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Blood samples are obtained for correlative studies at baseline after course 2 and at 12 weeks Samples are analyzed for interleukin-6 Flt-1 and VEGF levels
After completion of study therapy patients are followed every 3-6 months for up to 3 years
Primary
Determine the hematologic response rate in patients with relapsed or refractory multiple myeloma treated with bevacizumab
Determine the proportion of patients who are progression free and have not failed treatment after 1 year
Secondary
Determine the toxicity of this drug in these patient
Determine the time to disease progression in patients receiving this drug
Determine the overall survival and survival at 1 year in patients receiving this drug
OUTLINE This is an open-label study
Patients receive bevacizumab IV on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Blood samples are obtained for correlative studies at baseline after course 2 and at 12 weeks Samples are analyzed for interleukin-6 Flt-1 and VEGF levels
After completion of study therapy patients are followed every 3-6 months for up to 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 |
|---|---|---|---|
| MC0584 | OTHER | None | None |
| P30CA015083 | NIH | None | None |
| 05-004261 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |