Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028600
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2002-01-04
Brief Title:
Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2016-07
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 Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells The donated stem cells may also help destroy any remaining cancer cells graft-versus-tumor effect
PURPOSE This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma
PURPOSE This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES
Determine whether autologous peripheral blood stem cell transplantation PBSCT followed by non-myeloablative allogeneic PBSCT is associated with no more than 20 treatment-related mortality rates at 6 months in patients with multiple myeloma
Determine the response rate of patients treated with this regimen
Determine the percent donor chimerism in patients treated with this regimen
Determine the rate of graft-vs-host disease in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the disease-free and overall survival of patients treated with this regimen
Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until peripheral blood stem cell PBSC collection is complete
Approximately 2-4 weeks after PBSC collection patients receive melphalan IV over 15-30 minutes on day -2 Patients then undergo autologous PBSC transplantation PBSCT on day 0 Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover
Approximately 2-4 months after autologous PBSCT patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3 Patients undergo allogeneic PBSCT on day 0 Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover
Patients receive graft-vs-host disease GVHD prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1 3 and 6
After day 120 patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion DLI over 2 hours Patients may receive up to 3 DLIs every 8 weeks
Patients are followed every 3 months for 3 years every 6 months for 5 years and then annually for 15 years
PROJECTED ACCRUAL A maximum of 63 patients will be accrued for this study
Determine whether autologous peripheral blood stem cell transplantation PBSCT followed by non-myeloablative allogeneic PBSCT is associated with no more than 20 treatment-related mortality rates at 6 months in patients with multiple myeloma
Determine the response rate of patients treated with this regimen
Determine the percent donor chimerism in patients treated with this regimen
Determine the rate of graft-vs-host disease in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the disease-free and overall survival of patients treated with this regimen
Determine whether abnormal cytogenetics at presentation correlate with poor response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until peripheral blood stem cell PBSC collection is complete
Approximately 2-4 weeks after PBSC collection patients receive melphalan IV over 15-30 minutes on day -2 Patients then undergo autologous PBSC transplantation PBSCT on day 0 Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover
Approximately 2-4 months after autologous PBSCT patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3 Patients undergo allogeneic PBSCT on day 0 Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover
Patients receive graft-vs-host disease GVHD prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1 3 and 6
After day 120 patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion DLI over 2 hours Patients may receive up to 3 DLIs every 8 weeks
Patients are followed every 3 months for 3 years every 6 months for 5 years and then annually for 15 years
PROJECTED ACCRUAL A maximum of 63 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000069109 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-100001 | None | None | None |