Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022607
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-08-10
Brief Title:
Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
California Cancer Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for RelapsedRefractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 deliver cancer-killing substances to them Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor It is not yet known whether bevacizumab works better with or without thalidomide for multiple myeloma
PURPOSE This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma
PURPOSE This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma
Detailed Description:
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 psychologicalphysical 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 25 years
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 psychologicalphysical 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 25 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2712 | None | None | None |
| CCC-PHII-30 | None | None | None |
| CHNMC-PHII-30 | None | None | None |
| CHNMC-IRB-01006 | None | None | None |