Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma
OBJECTIVES:
- Compare the response rate and time to progression in patients with relapsed or
refractory multiple myeloma treated with bevacizumab with or without thalidomide.
- Compare the toxicity of these regimens in these patients.
- Compare the effects of these regimens on histological and molecular biomarkers of
angiogenesis, tumor invasion, and cell death in these patients.
- Correlate plasma and urine vascular endothelial growth factor and basic fibroblast
growth factor levels and other potential markers of angiogenesis and myeloma cell
proliferation with outcome in patients treated with these regimens.
- Determine the pharmacokinetics of thalidomide in these patients.
- Compare the effects of these regimens on the psychological/physical well being of these
patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
treatment with thalidomide (yes vs no).
Patients who have received no prior treatment with thalidomide are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43.
Patients also receive oral thalidomide once daily.
- Arm II: Patients receive bevacizumab as in arm I. Patients who have received prior
treatment with thalidomide receive bevacizumab as in arm I.
Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months and then every 3-4 months for 3 years.
PROJECTED ACCRUAL: A total of 55-103 patients (16-32 who have received prior thalidomide,
16-32 in arm I, and 23-39 in arm II) will be accrued for this study within 2.5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
United States: Federal Government
CDR0000068834
NCT00022607
January 2002
May 2006
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |