Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
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.
Multiple Myeloma and Plasma Cell Neoplasm
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma|
- Confirmed hematologic response [ Designated as safety issue: No ]
- Progression-free survival at 1 year [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482495
|United States, Minnesota|
|Rochester, Minnesota, United States, 55940|
|Study Chair:||Suzanne Hayman, MD||Mayo Clinic|