Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040937
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2002-07-08
Brief Title:
S0204 Thalidomide Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial Of ThalidomideDexamethasone Induction Followed By Tandem Melphalan Transplant And PrednisoneThalidomide Maintenance A BMT Study
Status:
COMPLETED
Status Verified Date:
2016-10
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 Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma
PURPOSE This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma
PURPOSE This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma
Detailed Description:
OBJECTIVES
Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma
Determine preliminarily the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients
Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen
Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen
Evaluate immune reconstitution and recovery after first and second transplantation in these patients
OUTLINE This is a multicenter study
Induction chemotherapy Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4 9-12 and 17-20 Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity
Stem cell mobilization and collection Beginning 5-7 days but no more than 3 weeks after completion of induction chemotherapy patients receive cyclophosphamide IV over 45-60 minutes on day 0 filgrastim G-CSF subcutaneously SC on days 1-10 and sargramostim GM-CSF SC beginning on day 1 and continuing until completion of peripheral blood stem cell PBSC collection Patients begin PBSC collection on day 11 or as soon as blood counts recover
First transplantation Within 3-6 weeks after cyclophosphamide administration patients receive melphalan IV over 20 minutes on day -1 Patients undergo PBSC infusion on day 0 Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover
Second transplantation Between 2-4 months after first transplantation patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above
Maintenance therapy Beginning 70-90 days post-transplantation patients receive oral prednisone every other day and oral thalidomide once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 12 months for 10 years
PROJECTED ACCRUAL Approximately 99 patients will be accrued for this study within 18 months
Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma
Determine preliminarily the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients
Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen
Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen
Evaluate immune reconstitution and recovery after first and second transplantation in these patients
OUTLINE This is a multicenter study
Induction chemotherapy Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4 9-12 and 17-20 Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity
Stem cell mobilization and collection Beginning 5-7 days but no more than 3 weeks after completion of induction chemotherapy patients receive cyclophosphamide IV over 45-60 minutes on day 0 filgrastim G-CSF subcutaneously SC on days 1-10 and sargramostim GM-CSF SC beginning on day 1 and continuing until completion of peripheral blood stem cell PBSC collection Patients begin PBSC collection on day 11 or as soon as blood counts recover
First transplantation Within 3-6 weeks after cyclophosphamide administration patients receive melphalan IV over 20 minutes on day -1 Patients undergo PBSC infusion on day 0 Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover
Second transplantation Between 2-4 months after first transplantation patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above
Maintenance therapy Beginning 70-90 days post-transplantation patients receive oral prednisone every other day and oral thalidomide once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 12 months for 10 years
PROJECTED ACCRUAL Approximately 99 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| S0204 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |