Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205764
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2005-09-12
Brief Title:
Tandem High Dose Melphalan Versus Triple Intermediate Dose Melphalan and Stem Cell Transplantation in Induction Phase and PrednisoloneIFN Versus IFN in Maintenance Therapy
Sponsor:
Austrian Forum Against Cancer
Organization:
Austrian Forum Against Cancer
Study Overview
Official Title:
Randomised Non-blind Parallel Group Study to Compare Tandem High Dose Melphalan 200mgm² Versus Triple Intermediate Dose Melphalan 100mgm² and Stem Cell Transplantation in Induction Phase and PrednisoloneIFN Versus IFN in Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-11
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:
This is an internationalmulticenter prospective open double randomised and controlled phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus triple intermediate dose Melpahaln in newly-diagnosed myeloma patients
Detailed Description:
Patients will be enrolled into this protocol before start of Induction therapy which consists of 3 cycles or VAD with a 4 week interval followed by 1 cycle of IEV after which stem cell harvesting is performed After stem cell harvesting is completed Patients will be randomised to one of the high dose therapy arms after response evaluation Complete remission Partial remission or stable disease One group is receiving 2 Cycles of Melphalan 200mgm² each followed by stem cell transplantation the other group is receiving 3 Cycles of Melphalan 100mgm² also followed by stem cell transplantation each time
After completing high dose therapy patients will be randomised into Maintenance responding with CR PR or SD The maintenance therapy will be continued until relapse or progression of disease as defined by the response criteria
After completing high dose therapy patients will be randomised into Maintenance responding with CR PR or SD The maintenance therapy will be continued until relapse or progression of disease as defined by the response criteria
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