Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008268
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-01-06
Brief Title:
Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study Of Blood Stem Cell Mobilization With Intravenous Melphalan 60 MGM2 G-CSF In Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood
PURPOSE Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma
PURPOSE Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of melphalan when used with filgrastim G-CSF for stem cell mobilization in patients with multiple myeloma
Analyze how this mobilization regimen affects parameters of stem cell CD34 mobilization and collection in these patients
Determine how this mobilization regimen affects disease status and clonotypic ie tumor cell contamination in stem cell components in these patients
OUTLINE Patients undergo peripheral blood stem cell PBSC mobilization consisting of melphalan IV on day 1 and filgrastim G-CSF subcutaneously beginning on day 2 and continuing until PBSC collection is complete
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 11-32 patients will be accrued for this study within 2 years
Determine the safety and efficacy of melphalan when used with filgrastim G-CSF for stem cell mobilization in patients with multiple myeloma
Analyze how this mobilization regimen affects parameters of stem cell CD34 mobilization and collection in these patients
Determine how this mobilization regimen affects disease status and clonotypic ie tumor cell contamination in stem cell components in these patients
OUTLINE Patients undergo peripheral blood stem cell PBSC mobilization consisting of melphalan IV on day 1 and filgrastim G-CSF subcutaneously beginning on day 2 and continuing until PBSC collection is complete
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 11-32 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1895 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068392 | REGISTRY | None | None |