Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005834
Status:
TERMINATED
Last Update Posted:
2015-03-06
First Post:
2000-06-02
Brief Title:
S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Trial of Dexamethasone Cyclophosphamide Etoposide Cisplatin DCEP and G-CSF With or Without Thalidomide NSC 66847 as Salvage Therapy for Patients With Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 tumor cells by stopping blood flow to the tumor It is not yet known if combination chemotherapy is more effective with or without thalidomide for multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have refractory multiple myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have refractory multiple myeloma
Detailed Description:
OBJECTIVES I Compare the overall and progression-free survival and remission rates in patients with refractory multiple myeloma treated with dexamethasone cyclophosphamide etoposide cisplatin and filgrastim G-CSF with or without thalidomide II Compare the qualitative and quantitative toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior transplantation yes vs no prior treatment failure resistant vs relapsing prior treatment regimens 1-2 vs 3-4 and prior thalidomide no vs some Patients are randomized to one of two treatment arms Arm I Patients receive oral dexamethasone daily and cyclophosphamide etoposide and cisplatin DCEP IV continuously on days 1-4 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 5 and continuing until blood counts recover Treatment continues every 3-4 weeks for 3 courses Patients achieving stable disease or better proceed to maintenance chemotherapy with DCEP administered every 8 weeks for 3 additional courses Arm II Patients receive chemotherapy with DCEP as in arm I plus oral thalidomide daily Thalidomide continues with maintenance chemotherapy and then continues after chemotherapy is completed until disease progression Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 320 patients will be accrued for this study within 4 years
OUTLINE This is a randomized multicenter study Patients are stratified according to prior transplantation yes vs no prior treatment failure resistant vs relapsing prior treatment regimens 1-2 vs 3-4 and prior thalidomide no vs some Patients are randomized to one of two treatment arms Arm I Patients receive oral dexamethasone daily and cyclophosphamide etoposide and cisplatin DCEP IV continuously on days 1-4 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 5 and continuing until blood counts recover Treatment continues every 3-4 weeks for 3 courses Patients achieving stable disease or better proceed to maintenance chemotherapy with DCEP administered every 8 weeks for 3 additional courses Arm II Patients receive chemotherapy with DCEP as in arm I plus oral thalidomide daily Thalidomide continues with maintenance chemotherapy and then continues after chemotherapy is completed until disease progression Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 320 patients 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 | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9922 | OTHER | None | None |