Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002810
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
1999-11-01
Brief Title:
High-Dose Melphalan Followed by Peripheral Stem Cell Transplant in Treating Patients With Amyloidosis
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis AL
Status:
COMPLETED
Status Verified Date:
2010-09
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 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 peripheral 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 giving high-dose melphalan together with peripheral stem cell transplant works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma
PURPOSE This phase II trial is studying how well giving high-dose melphalan together with peripheral stem cell transplant works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma
Detailed Description:
OBJECTIVES
Assess overall and progression-free survival following high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with primary amyloidosis
Evaluate the toxic effects associated with this treatment regimen
Evaluate the function of involved organs especially the heart lungs and nervous system before and after treatment with this regimen
OUTLINE Peripheral blood stem cells PBSC are mobilized with granulocyte colony-stimulating factor G-CSF for 5 days and then collected by leukapheresis Patients receive high-dose melphalan on 2 consecutive days followed by 1 day of rest then by PBSC transplantation G-CSF is given from 1 day after transplantation until the neutrophil count is greater than 1500 for 3 consecutive days
Patients are followed at 100 days and 1 year post-transplant
PROJECTED ACCRUAL A very small number of patients are expected to be accrued over 5-10 years
Assess overall and progression-free survival following high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with primary amyloidosis
Evaluate the toxic effects associated with this treatment regimen
Evaluate the function of involved organs especially the heart lungs and nervous system before and after treatment with this regimen
OUTLINE Peripheral blood stem cells PBSC are mobilized with granulocyte colony-stimulating factor G-CSF for 5 days and then collected by leukapheresis Patients receive high-dose melphalan on 2 consecutive days followed by 1 day of rest then by PBSC transplantation G-CSF is given from 1 day after transplantation until the neutrophil count is greater than 1500 for 3 consecutive days
Patients are followed at 100 days and 1 year post-transplant
PROJECTED ACCRUAL A very small number of patients are expected to be accrued over 5-10 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 |
|---|---|---|---|
| NCI-V96-0951 | None | None | None |
| TUHSC-2797 | None | None | None |