Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064337
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2003-07-08
Brief Title:
S0115 High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0115 A Phase II Trial Evaluating Modified High Dose Melphalan 100 mgm And Autologous Peripheral Blood Stem Cell Supported Transplant SCT For High Risk Patients With Multiple Myeloma AndOr Light Chain Amyloidosis AL Amyloidosis A BMT Study
Status:
COMPLETED
Status Verified Date:
2018-07
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 such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well giving melphalan together with autologous stem cell transplantation works in treating patients with multiple myeloma or primary systemic amyloidosis
PURPOSE This phase II trial is studying how well giving melphalan together with autologous stem cell transplantation works in treating patients with multiple myeloma or primary systemic amyloidosis
Detailed Description:
OBJECTIVES
Determine overall survival of patients with high-risk multiple myeloma primary systemic amyloidosis or light chain deposition disease treated with two courses of modified high-dose melphalan and autologous peripheral blood stem cell transplantation
Determine the hematologic response in patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the prognostic significance of cytogenetic markers in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease high-risk multiple myeloma vs primary systemic amyloidosis vs both
Induction therapy multiple myeloma patients only Patients receive oral dexamethasone on days 1-4 9-12 and 17-20 and oral thalidomide daily on days 1-35 Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity
Mobilization and stem cell collection
Multiple myeloma patients Within 28-35 days after completion of induction therapy patients receive cyclophosphamide IV over 2-3 hours on day 1 and filgrastim G-CSF subcutaneously SC daily beginning on day 2 and continuing through the day before the last leukapheresis Usage of mesna IV on day 1 prior to and twice after cyclophosphamide administration is recommended
Primary systemic amyloidosis patients Patients receive G-CSF SC daily beginning on day 1 and continuing through the day before the last leukapheresis
All patients undergo leukapheresis for the collection of stem cells until the target number of CD34 cells is reached
Conditioning regimen Within 1-4 weeks after mobilization patients receive modified high-dose melphalan IV over 20 minutes on day -2
Peripheral blood stem cell PBSC reinfusion PBSCs are reinfused on day 0 Patients receive G-CSF SC daily beginning on day 1 and continuing until blood counts recover
Patients undergo a second autologous PBSC transplantation within 3-6 months but no later than 12 months after the first transplantation
Second conditioning regimen Patients receive modified high-dose melphalan IV over 20 minutes on day -2
Second PBSC infusion PBSCs are infused on day 0
Maintenance regimen multiple myeloma patients only Between 4-8 weeks after the second transplantation patients with no progressive disease receive oral dexamethasone once daily on days 1-4 and oral thalidomide once daily on days 1-28 Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 and 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 20-25 months
Determine overall survival of patients with high-risk multiple myeloma primary systemic amyloidosis or light chain deposition disease treated with two courses of modified high-dose melphalan and autologous peripheral blood stem cell transplantation
Determine the hematologic response in patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine the prognostic significance of cytogenetic markers in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease high-risk multiple myeloma vs primary systemic amyloidosis vs both
Induction therapy multiple myeloma patients only Patients receive oral dexamethasone on days 1-4 9-12 and 17-20 and oral thalidomide daily on days 1-35 Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity
Mobilization and stem cell collection
Multiple myeloma patients Within 28-35 days after completion of induction therapy patients receive cyclophosphamide IV over 2-3 hours on day 1 and filgrastim G-CSF subcutaneously SC daily beginning on day 2 and continuing through the day before the last leukapheresis Usage of mesna IV on day 1 prior to and twice after cyclophosphamide administration is recommended
Primary systemic amyloidosis patients Patients receive G-CSF SC daily beginning on day 1 and continuing through the day before the last leukapheresis
All patients undergo leukapheresis for the collection of stem cells until the target number of CD34 cells is reached
Conditioning regimen Within 1-4 weeks after mobilization patients receive modified high-dose melphalan IV over 20 minutes on day -2
Peripheral blood stem cell PBSC reinfusion PBSCs are reinfused on day 0 Patients receive G-CSF SC daily beginning on day 1 and continuing until blood counts recover
Patients undergo a second autologous PBSC transplantation within 3-6 months but no later than 12 months after the first transplantation
Second conditioning regimen Patients receive modified high-dose melphalan IV over 20 minutes on day -2
Second PBSC infusion PBSCs are infused on day 0
Maintenance regimen multiple myeloma patients only Between 4-8 weeks after the second transplantation patients with no progressive disease receive oral dexamethasone once daily on days 1-4 and oral thalidomide once daily on days 1-28 Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 and 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 20-25 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0115 | OTHER | None | None |