Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014508
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2001-04-10
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2023-06
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 be able to replace immune cells that were destroyed by chemotherapy Sometimes the transplanted cells are rejected by the bodys tissues Peripheral stem cell transplantation with the persons own stem cells followed by donor peripheral stem cell transplantation may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with autologous peripheral stem cell transplantation and donor peripheral stem cell transplantation in treating patients who have multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with autologous peripheral stem cell transplantation and donor peripheral stem cell transplantation in treating patients who have multiple myeloma
Detailed Description:
OBJECTIVES
Determine the incidence of early mortality in patients with multiple myeloma treated with melphalan and autologous peripheral blood stem cell PBSC transplantation followed by fludarabine cyclophosphamide and allogeneic PBSC transplantation
Determine the incidence of early allogeneic graft failure before day 100 after allogeneic PBSC transplantation and the incidence of severe acute graft-versus-host disease GVHD in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the overall and disease-free survival of patients treated with this regimen
Correlate changes in the T-cell population with clinical outcome such as survival in patients treated with this regimen
Correlate changes in the T-cell population with the incidence of GVHD use of immunosuppressive agents and effects of fludarabine in patients treated with this regimen
Determine the degree of chimerism after allogeneic PBSC transplantation and the time course over which it is established in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive melphalan IV over 15 minutes on day -1 Autologous peripheral blood stem cells PBSCs are reinfused on day 0 Patients also receive sargramostim GM-CSF subcutaneously SC or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover Beginning 100-182 days after autologous PBSC transplantation patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -3 and -2 Allogeneic PBSCs are infused on day 0 Patients may receive a second allogeneic PBSC infusion on day 1 Patients also receive GM-CSF SC or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover Cyclosporine is administered IV or orally twice daily as graft-versus-host disease GVHD prophylaxis beginning on day -1 and continuing until day 60 followed by a taper in the absence of GVHD
Patients are followed for 5 years
PROJECTED ACCRUAL A total 19-46 patients will be accrued for this study within 3 years
Determine the incidence of early mortality in patients with multiple myeloma treated with melphalan and autologous peripheral blood stem cell PBSC transplantation followed by fludarabine cyclophosphamide and allogeneic PBSC transplantation
Determine the incidence of early allogeneic graft failure before day 100 after allogeneic PBSC transplantation and the incidence of severe acute graft-versus-host disease GVHD in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the overall and disease-free survival of patients treated with this regimen
Correlate changes in the T-cell population with clinical outcome such as survival in patients treated with this regimen
Correlate changes in the T-cell population with the incidence of GVHD use of immunosuppressive agents and effects of fludarabine in patients treated with this regimen
Determine the degree of chimerism after allogeneic PBSC transplantation and the time course over which it is established in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive melphalan IV over 15 minutes on day -1 Autologous peripheral blood stem cells PBSCs are reinfused on day 0 Patients also receive sargramostim GM-CSF subcutaneously SC or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover Beginning 100-182 days after autologous PBSC transplantation patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -3 and -2 Allogeneic PBSCs are infused on day 0 Patients may receive a second allogeneic PBSC infusion on day 1 Patients also receive GM-CSF SC or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover Cyclosporine is administered IV or orally twice daily as graft-versus-host disease GVHD prophylaxis beginning on day -1 and continuing until day 60 followed by a taper in the absence of GVHD
Patients are followed for 5 years
PROJECTED ACCRUAL A total 19-46 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E4A98 | None | None | None |