Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344526
Status:
COMPLETED
Last Update Posted:
2007-06-28
First Post:
2006-06-22
Brief Title:
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Autologous Stem Cell Transplantation ASCT Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL PrimaryAmyloidosis A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2007-06
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:
AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive deposition of amyloid fibrils derived from monoclonal Ig light chains leading to multisystem organ failure and death The prognosis for AL amyloidosis with conventional treatment remains poor Autologous stem cell transplantation ASCT for AL amyloidosis produces high hematologic and organ responses However treatment-related mortality remains high and reported series are subject to selection bias
Detailed Description:
A prospective randomized trial was conducted to compare in AL amyloidosis ASCT melphalan 140 or 200 mgm2 depending on age and clinical status supported with ASCT collected with G-CSF alone and the oral regimen M-Dex melphalan 10 mgm2 and dexamethasone 40 mg for 4 days each months up to 18 months The objectives were to compare survival and hematologic and clinical responses
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