Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049673
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2002-11-12
Brief Title:
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2023-09
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 Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma
PURPOSE This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma
PURPOSE This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma
Detailed Description:
OBJECTIVES
Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation
Compare progression-free survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare toxic effects of these regimens in these patients
Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens
OUTLINE This is a randomized non-blinded multicenter study Patients are stratified according to treatment center age under 60 vs 60 and over and response to prior transplantation complete vs incomplete Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation
For both arms patients are assessed including for quality of life regularly throughout the treatmentobservation period at baseline every 2 months for 6 months every 3 months for up to 4 years and then annually thereafter
After the treatmentobservation period patients are followed annually
PROJECTED ACCRUAL A total of 324 patients will be accrued for this study within 35 years
Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation
Compare progression-free survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare toxic effects of these regimens in these patients
Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens
OUTLINE This is a randomized non-blinded multicenter study Patients are stratified according to treatment center age under 60 vs 60 and over and response to prior transplantation complete vs incomplete Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation
For both arms patients are assessed including for quality of life regularly throughout the treatmentobservation period at baseline every 2 months for 6 months every 3 months for up to 4 years and then annually thereafter
After the treatmentobservation period patients are followed annually
PROJECTED ACCRUAL A total of 324 patients will be accrued for this study within 35 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-JMY10 | OTHER | None | None |
| ECOG-NCIC-JMY10 | OTHER | None | None |
| CELGENE-CAN-NCIC-MY10 | OTHER | None | None |
| CDR0000258158 | OTHER | PDQ | None |