Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT00482495
Status:
COMPLETED
Last Update Posted:
2011-05-11
First Post:
2007-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
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:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| MC0584 | OTHER | Mayo Clinic Cancer Center | View | |
| 05-004261 | OTHER | Mayo Clinic IRB | View |