Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075621
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2004-01-09
Brief Title:
Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic AL Amyloidosis
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
A Phase II Trial of Tandem Transplantation in AL Amyloidosis
Status:
COMPLETED
Status Verified Date:
2020-09
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 Autologous stem cell transplantation may be effective treatment for primary systemic AL amyloidosis
PURPOSE This phase II trial is studying how well tandem two autologous stem cell transplantation works in treating patients with primary systemic AL amyloidosis
PURPOSE This phase II trial is studying how well tandem two autologous stem cell transplantation works in treating patients with primary systemic AL amyloidosis
Detailed Description:
OBJECTIVES
Determine the tolerability of tandem autologous stem cell transplantation in patients with AL amyloidosis
Determine whether this regimen can convert a hematologic non-complete response CR to CR in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE
First transplantation Patients receive filgrastim G-CSF subcutaneously once daily beginning 3 days before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection Patients may undergo bone marrow harvest if an inadequate number of peripheral blood stem cells are collected
Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2 Patients undergo autologous stem cell transplantation ASCT on day 0
Second transplantation Within 6-12 months after the first ASCT patients not achieving a complete response receive high-dose melphalan IV over 20 minutes on days -3 and -2 and a second ASCT on day 0
Treatment continues in the absence of unacceptable toxicity
Patients are followed at 3 and 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study within 2-3 years
Determine the tolerability of tandem autologous stem cell transplantation in patients with AL amyloidosis
Determine whether this regimen can convert a hematologic non-complete response CR to CR in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE
First transplantation Patients receive filgrastim G-CSF subcutaneously once daily beginning 3 days before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection Patients may undergo bone marrow harvest if an inadequate number of peripheral blood stem cells are collected
Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2 Patients undergo autologous stem cell transplantation ASCT on day 0
Second transplantation Within 6-12 months after the first ASCT patients not achieving a complete response receive high-dose melphalan IV over 20 minutes on days -3 and -2 and a second ASCT on day 0
Treatment continues in the absence of unacceptable toxicity
Patients are followed at 3 and 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study within 2-3 years
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?:
False
Is an FDA AA801 Violation?:
None