Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207805
Status:
COMPLETED
Last Update Posted:
2009-01-27
First Post:
2005-09-13
Brief Title:
The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients 61 Years With Multiple Myeloma
Sponsor:
Centre National de Greffe de Moelle Osseuse
Organization:
Centre National de Greffe de Moelle Osseuse
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-01
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:
Autologous peripheral blood stem cell PBSC transplantation is now considered standard therapy in patients 65 ans with multiple myeloma The Intergroupe Francophone du Myelome conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy followed by either one or two successive autologous stem cell transplantation The probabilities of event-free-survival and overall survival were doubled with a double transplant The benefits were greatest among patients who had not had a very good partial response to the first transplant
The aim of this multicenter randomised trial in previously untreated patients with multiple myelome stage II III DSis to assess the optimal timing of a second autologous stem-cell transplantAfter a first-line therapy with thalidomide-dexamethasone followed by a PBSC collection patients are randomly assigned to receive two autologous PBSC transplants arm Aor one autologous PBSC transplant followed by a consolidation therapy with thalidomide-dexamethasone arm B Patients included in the arm B will receive a second transplant in case of disease progression on consolidation therapy or in case of relapse in responders
The aim of this multicenter randomised trial in previously untreated patients with multiple myelome stage II III DSis to assess the optimal timing of a second autologous stem-cell transplantAfter a first-line therapy with thalidomide-dexamethasone followed by a PBSC collection patients are randomly assigned to receive two autologous PBSC transplants arm Aor one autologous PBSC transplant followed by a consolidation therapy with thalidomide-dexamethasone arm B Patients included in the arm B will receive a second transplant in case of disease progression on consolidation therapy or in case of relapse in responders
Detailed Description:
None
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