Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006890
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2000-12-06
Brief Title:
Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2020-03
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 Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor Prednisone may be effective in preventing relapse of multiple myeloma
PURPOSE Randomized phase II trial to compare the effectiveness of two doses of thalidomide combined with prednisone following peripheral stem cell transplantation in treating patients who have multiple myeloma
PURPOSE Randomized phase II trial to compare the effectiveness of two doses of thalidomide combined with prednisone following peripheral stem cell transplantation in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES I Determine which dose of thalidomide 200 mg vs 400 mg combined with prednisone is the optimally tolerated dose when used as maintenance therapy following autologous stem cell transplantation in patients with multiple myeloma II Compare the response rate in patients treated with these regimens III Compare the progression-free and overall survival in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 60 and over vs under 60 Within 60-100 days after autologous stem cell transplantation patients are randomized to 1 of 2 treatment arms Arm I Patients receive lower dose oral thalidomide daily and oral prednisone every other day Arm II Patients receive higher dose thalidomide daily and oral prednisone every other day Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity Patients are followed monthly for 6 months every 3 months and then at time of disease progression
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per arm will be accrued for this study within 17-21 months
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to age 60 and over vs under 60 Within 60-100 days after autologous stem cell transplantation patients are randomized to 1 of 2 treatment arms Arm I Patients receive lower dose oral thalidomide daily and oral prednisone every other day Arm II Patients receive higher dose thalidomide daily and oral prednisone every other day Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity Patients are followed monthly for 6 months every 3 months and then at time of disease progression
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per arm will be accrued for this study within 17-21 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000068337 | OTHER | PDQ | None |
| CAN-NCIC-MY9 | OTHER | None | None |
| CELGENE-CAN-NCIC-MY9 | OTHER | None | None |