Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00482495|
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : May 11, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Biological: bevacizumab Genetic: gene expression analysis Genetic: protein expression analysis Other: laboratory biomarker analysis||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||November 2009|
U.S. FDA Resources
- Confirmed hematologic response
- Progression-free survival at 1 year
- Toxicity as measured by NCI CTCAE v3.0
- Time to progression
- Duration of response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482495
|United States, Minnesota|
|Rochester, Minnesota, United States, 55940|
|Study Chair:||Suzanne Hayman, MD||Mayo Clinic|