Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064038
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2003-07-08
Brief Title:
S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I Stage II or Stage III Multiple Myeloma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Trial Comparing Dexamethasone DEX to the Combination of DEX CC-5013 in Patients With Previously Untreated Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2015-03
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 such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma
PURPOSE This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I stage II or stage III multiple myeloma
PURPOSE This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I stage II or stage III multiple myeloma
Detailed Description:
OBJECTIVES
Compare the progression-free survival of patients with previously untreated stage I II or III multiple myeloma treated with dexamethasone with or without lenalidomide
Compare the overall response rate in patients treated with these regimens
Compare the major response rate indicated by greater than 75 decrease in M-protein in patients treated with these regimens
Compare the overall survival and time to best response in patients treated with these regimens
Compare the toxicity profile of these regimens including thrombotic complications in these patients
Compare the effect of these regimens on gene expression and proteomic analysis in these patients
OUTLINE This is a randomized double-blind crossover multicenter study Patients are stratified according to disease stage by the International Staging System I vs II vs III and Zubrod performance status 0-1 vs 2-3 Patients are randomized to 1 of 2 treatment arms
Arm I
Induction therapy Patients receive oral dexamethasone DM on days 1-4 9-12 and 17-20 and oral lenalidomide on days 1-28 Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Maintenance therapy Patients receive oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II
Induction therapy Patients receive DM as in arm I induction and oral placebo on days 1-28 Treatment repeats as in arm I induction
Patients with responding or stable disease proceed to maintenance therapy Patients with disease progression during induction therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction Patients with responding or stable disease after unblinded induction therapy receive unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance
Maintenance therapy Patients receive oral DM as in arm I maintenance and oral placebo on days 1-21 Courses repeat as in arm I maintenance
Patients with disease progression during maintenance therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction Patients with responding or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance
Patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study within 4 years
Compare the progression-free survival of patients with previously untreated stage I II or III multiple myeloma treated with dexamethasone with or without lenalidomide
Compare the overall response rate in patients treated with these regimens
Compare the major response rate indicated by greater than 75 decrease in M-protein in patients treated with these regimens
Compare the overall survival and time to best response in patients treated with these regimens
Compare the toxicity profile of these regimens including thrombotic complications in these patients
Compare the effect of these regimens on gene expression and proteomic analysis in these patients
OUTLINE This is a randomized double-blind crossover multicenter study Patients are stratified according to disease stage by the International Staging System I vs II vs III and Zubrod performance status 0-1 vs 2-3 Patients are randomized to 1 of 2 treatment arms
Arm I
Induction therapy Patients receive oral dexamethasone DM on days 1-4 9-12 and 17-20 and oral lenalidomide on days 1-28 Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Maintenance therapy Patients receive oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II
Induction therapy Patients receive DM as in arm I induction and oral placebo on days 1-28 Treatment repeats as in arm I induction
Patients with responding or stable disease proceed to maintenance therapy Patients with disease progression during induction therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction Patients with responding or stable disease after unblinded induction therapy receive unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance
Maintenance therapy Patients receive oral DM as in arm I maintenance and oral placebo on days 1-21 Courses repeat as in arm I maintenance
Patients with disease progression during maintenance therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction Patients with responding or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance
Patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 500 patients 250 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0232 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |