Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367185
Status:
COMPLETED
Last Update Posted:
2006-08-22
First Post:
2006-08-21
Brief Title:
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Comparison of Melphalan-PrednisoneMPMP-THALIDOMIDEand Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2006-04
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:
In multiple myeloma combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy using a melphalan 100 mgm2 -based regimen would improve survival
Detailed Description:
Trial design This multicenter randomized controlled trial is conducted by the French Myeloma IntergroupIFM in elderly patients with previously untreated multiple myeloma The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 intermediate-dose melphalan 100 mgm2 - based treatment The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100
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