Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017680
Status:
COMPLETED
Last Update Posted:
2008-06-09
First Post:
2001-06-06
Brief Title:
Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in
Status:
COMPLETED
Status Verified Date:
2008-06
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:
OBJECTIVES I Determine the response disease-free survival and overall survival of patients with primary light chain amyloidosis treated with high-dose melphalan and autologous stem cell transplantation
II Determine the toxicity of this regimen in these patients
II Determine the toxicity of this regimen in these patients
Detailed Description:
PROTOCOL OUTLINE Patients may receive induction chemotherapy before study entry Patients then receive filgrastim G-CSF or another growth factor for 4-6 days as peripheral blood stem cell PBSC mobilization PBSC or bone marrow is harvested over 2-3 days
Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1 PBSC andor bone marrow is reinfused on day 0 Patients receive G-CSF beginning on day 0 and continuing until blood counts recover This course may be repeated 4-12 weeks later
Patients are followed every 3 months for 1 year and then annually for 5 years
Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1 PBSC andor bone marrow is reinfused on day 0 Patients receive G-CSF beginning on day 0 and continuing until blood counts recover This course may be repeated 4-12 weeks later
Patients are followed every 3 months for 1 year and then annually for 5 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 |
|---|---|---|---|
| CPMC-CAMP-009A | None | None | None |
| CPMC-IRB-9041 | None | None | None |