Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033332
Status:
COMPLETED
Last Update Posted:
2014-04-04
First Post:
2002-04-09
Brief Title:
Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial Of Thalidomide NSC 66847 Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2005-11
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Combining dexamethasone and thalidomide may kill more cancer cells It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma
PURPOSE Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma
PURPOSE Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES
Compare the response rate of patients with newly diagnosed multiple myeloma treated with dexamethasone with or without thalidomide
Compare the toxicity of these regimens in these patients
Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis grade and on the expression of vascular endothelial growth factor and basic fibroblast growth factor in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone once daily on days 1-4 9-12 and 17-20 Patients also receive either pamidronate IV over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening
Arm II Patients receive dexamethasone and pamidronate or zoledronate as in arm I
Treatment in both arms repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients may receive additional courses after the fourth course at the physicians discretion
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 2 years
PROJECTED ACCRUAL A total of 194 patients 97 per treatment arm will be accrued for this study
Compare the response rate of patients with newly diagnosed multiple myeloma treated with dexamethasone with or without thalidomide
Compare the toxicity of these regimens in these patients
Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis grade and on the expression of vascular endothelial growth factor and basic fibroblast growth factor in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone once daily on days 1-4 9-12 and 17-20 Patients also receive either pamidronate IV over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening
Arm II Patients receive dexamethasone and pamidronate or zoledronate as in arm I
Treatment in both arms repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients may receive additional courses after the fourth course at the physicians discretion
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 2 years
PROJECTED ACCRUAL A total of 194 patients 97 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| E-E1A00 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |