Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004165
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Brief Title:
Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-05
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 use different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of melphalan followed by peripheral stem cell transplantation in treating patients who have multiple myeloma
PURPOSE Phase III trial to study the effectiveness of melphalan followed by peripheral stem cell transplantation in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES
Administer standard high dose melphalan safely in a closely monitored setting in patients with responsive multiple myeloma
Determine the cost and time effectiveness in the collection of sufficient peripheral blood stem cells PBSC for two high dose melphalan therapies and PBSC transplantations in this patient population
OUTLINE Patients not in remission receive 3-6 courses of remission induction therapy consisting of either an anthracyclineglucocorticoid regimen or high dose glucocorticoids
At 21-45 days following induction therapy patients receive filgrastim G-CSF subcutaneously daily for 4 days followed by daily peripheral blood stem cell PBSC collection beginning on day 4 and continuing until the target number of cells is reached
At 5 days to 6 weeks following PBSC collection patients receive high dose melphalan IV over 2 hours for 2 consecutive days At 36-48 hours following completion of melphalan patients receive infusion of PBSC followed by G-CSF subcutaneously daily until blood counts recover
At 3 months to 5 years following high dose therapy and PBSC infusion patients with evidence of disease progression receive an additional treatment with high dose melphalan followed by PBSC infusion as in the first course
Patients are followed at 30-45 days 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 60-120 patients will be accrued for this study over 5 years
Administer standard high dose melphalan safely in a closely monitored setting in patients with responsive multiple myeloma
Determine the cost and time effectiveness in the collection of sufficient peripheral blood stem cells PBSC for two high dose melphalan therapies and PBSC transplantations in this patient population
OUTLINE Patients not in remission receive 3-6 courses of remission induction therapy consisting of either an anthracyclineglucocorticoid regimen or high dose glucocorticoids
At 21-45 days following induction therapy patients receive filgrastim G-CSF subcutaneously daily for 4 days followed by daily peripheral blood stem cell PBSC collection beginning on day 4 and continuing until the target number of cells is reached
At 5 days to 6 weeks following PBSC collection patients receive high dose melphalan IV over 2 hours for 2 consecutive days At 36-48 hours following completion of melphalan patients receive infusion of PBSC followed by G-CSF subcutaneously daily until blood counts recover
At 3 months to 5 years following high dose therapy and PBSC infusion patients with evidence of disease progression receive an additional treatment with high dose melphalan followed by PBSC infusion as in the first course
Patients are followed at 30-45 days 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 60-120 patients will be accrued for this study over 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 |
|---|---|---|---|
| NCI-G99-1632 | None | None | None |
| NU-97H6T | None | None | None |