Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005987
Status:
TERMINATED
Last Update Posted:
2017-11-29
First Post:
2000-07-05
Brief Title:
Filgrastim Compared With Sargramostim Plus Chemotherapy Peripheral Stem Cell Transplantation and Interferon Alfa in Treating Patients With Multiple Myeloma
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Autologous Transplantation for Multiple Myeloma A Research Study of Multiple Myeloma Using Chemotherapy Plus Growth Factor Primed Peripheral Blood Stem Cells Followed by Autologous Transplantation and Post-Transplant Immunotherapy
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn because treatment guidelines changed
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 Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy Interferon alfa may interfere with the growth of cancer cells It is not yet known which treatment regimen is more effective for multiple myeloma
PURPOSE Randomized phase II trial to compare the effectiveness of filgrastim with that of sargramostim plus chemotherapy peripheral stem cell transplantation and interferon alfa in treating patients who have multiple myeloma
PURPOSE Randomized phase II trial to compare the effectiveness of filgrastim with that of sargramostim plus chemotherapy peripheral stem cell transplantation and interferon alfa in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES
Compare disease control and extended survival in patients with multiple myeloma when treated with either filgrastim G-CSF or sargramostim GM-CSF plus high-dose chemotherapy followed by autologous peripheral blood stem cell PBSC transplantation followed by interferon alfa
Determine whether these priming treatments induce sufficient mobilization of circulating PBSC to allow their collection by leukapheresis for subsequent use in autologous transplantation in these patients
Determine whether these treatments induce complete response in conjunction with rapid hematopoietic recovery and modest transplant-associated morbidity and mortality in this patient population
Determine whether interferon alfa given as maintenance immunostimulatory therapy for patients achieving significant cytoreduction post transplantation can prevent or delay malignant relapse in these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I In the priming phase patients receive cyclophosphamide IV over 2 hours on day 1 mitoxantrone IV over 1 hour daily on days 1-2 and dexamethasone IV every 12 hours beginning on day 1 for a total of 4 doses Patients also receive sargramostim GM-CSF IV over 2 hours or subcutaneously SC daily beginning 48 hours after the last dose of mitoxantrone and continuing until completion of leukapheresis Peripheral blood stem cells PBSC are collected daily on days 11-13 after neutrophil recovery
Arm II In the priming phase patients receive the same treatment as in arm I except these patients receive filgrastim G-CSF IV over 15 minutes or SC in place of GM-CSF
In the transplant phase patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 and -5 and total body irradiation twice daily on days -3 through -1 Autologous PBSC are reinfused on day 0 Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover
Patients who have received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 through -3 carmustine IV over 1 hour on day -6 and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4 Autologous PBSC are reinfused on day 0 Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover
All patients then receive interferon alfa SC 3 times weekly starting on day 28 and continuing until relapse or disease progression
Patients may also undergo radiotherapy 5 days a week for 2 weeks for residual bony lesions measuring greater than 2 cm
Patients are followed at days 28 and 100 and at 6 9 12 18 24 30 and 36 months
PROJECTED ACCRUAL A total of 25-35 patients will be accrued for this study within 2-3 years
Compare disease control and extended survival in patients with multiple myeloma when treated with either filgrastim G-CSF or sargramostim GM-CSF plus high-dose chemotherapy followed by autologous peripheral blood stem cell PBSC transplantation followed by interferon alfa
Determine whether these priming treatments induce sufficient mobilization of circulating PBSC to allow their collection by leukapheresis for subsequent use in autologous transplantation in these patients
Determine whether these treatments induce complete response in conjunction with rapid hematopoietic recovery and modest transplant-associated morbidity and mortality in this patient population
Determine whether interferon alfa given as maintenance immunostimulatory therapy for patients achieving significant cytoreduction post transplantation can prevent or delay malignant relapse in these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I In the priming phase patients receive cyclophosphamide IV over 2 hours on day 1 mitoxantrone IV over 1 hour daily on days 1-2 and dexamethasone IV every 12 hours beginning on day 1 for a total of 4 doses Patients also receive sargramostim GM-CSF IV over 2 hours or subcutaneously SC daily beginning 48 hours after the last dose of mitoxantrone and continuing until completion of leukapheresis Peripheral blood stem cells PBSC are collected daily on days 11-13 after neutrophil recovery
Arm II In the priming phase patients receive the same treatment as in arm I except these patients receive filgrastim G-CSF IV over 15 minutes or SC in place of GM-CSF
In the transplant phase patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 and -5 and total body irradiation twice daily on days -3 through -1 Autologous PBSC are reinfused on day 0 Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover
Patients who have received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -6 through -3 carmustine IV over 1 hour on day -6 and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4 Autologous PBSC are reinfused on day 0 Patients also receive GM-CSF IV over 2 hours daily and G-CSF IV over 15 minutes daily beginning on day 0 and continuing until day 28 or until blood counts recover
All patients then receive interferon alfa SC 3 times weekly starting on day 28 and continuing until relapse or disease progression
Patients may also undergo radiotherapy 5 days a week for 2 weeks for residual bony lesions measuring greater than 2 cm
Patients are followed at days 28 and 100 and at 6 9 12 18 24 30 and 36 months
PROJECTED ACCRUAL A total of 25-35 patients will be accrued for this study within 2-3 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 |
|---|---|---|---|
| UMN-MT-1992-16 | None | None | None |
| UMN-MT-9216 | None | None | None |