Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase II Trial of Bevacizumab in 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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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