Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075608
Status:
TERMINATED
Last Update Posted:
2017-01-27
First Post:
2004-01-09
Brief Title:
2nd Autologous Stem Cell Transplant in Patients With PersistentRecurrent AL Amyloidosis
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Phase II Trial of Second Autologous Transplantation in AL Amyloidosis
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of plasma cells either by killing the cells or by stopping them from dividing Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy allows higher doses of chemotherapy to be given so that more plasma cells are killed By reducing the number of plasma cells the disease may progress more slowly
PURPOSE This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic AL amyloidosis
PURPOSE This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic AL amyloidosis
Detailed Description:
OBJECTIVES
Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis
Determine the response rate and durability of response in patients treated with this regimen
Determine immune reconstitution in patients treated with this regimen
OUTLINE
Mobilization Patients receive filgrastim G-CSF subcutaneously SC once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection
Preparative regimen Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2
Autologous stem cell transplantation Autologous stem cells are reinfused on day 0
Patients are followed at 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 19 patients will be accrued for this study within 5-6 years
Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis
Determine the response rate and durability of response in patients treated with this regimen
Determine immune reconstitution in patients treated with this regimen
OUTLINE
Mobilization Patients receive filgrastim G-CSF subcutaneously SC once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection
Preparative regimen Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2
Autologous stem cell transplantation Autologous stem cells are reinfused on day 0
Patients are followed at 6 months 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 19 patients will be accrued for this study within 5-6 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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-22603 | OTHER | Boston University Medical Center IRB | None |