Trials / Completed
CompletedNCT00482495
Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | bevacizumab | |
| GENETIC | gene expression analysis | |
| GENETIC | protein expression analysis | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2006-12-01
- Completion
- 2009-11-01
- First posted
- 2007-06-05
- Last updated
- 2011-05-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00482495. Inclusion in this directory is not an endorsement.