Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007995
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2001-01-06
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis
Status:
COMPLETED
Status Verified Date:
2007-07
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 use 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
PURPOSE This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with multiple myeloma or primary systemic amyloidosis
PURPOSE This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with multiple myeloma or primary systemic amyloidosis
Detailed Description:
OBJECTIVES
Determine the response rate in patients with multiple myeloma or primary systemic amyloidosis treated with high-dose chemotherapy with autologous hematopoietic stem cell support
Determine the toxicity of this regimen in these patients
Determine the disease-free survival and overall survival of patients with multiple myeloma treated with this regimen
OUTLINE Patients are stratified according to disease response to prior treatment responsive vs refractory or relapsed and diagnosis multiple myeloma vs primary systemic amyloidosis
Following a course of induction chemotherapy patients receive filgrastim G-CSF subcutaneously SC daily until the completion of peripheral blood stem cell PBSC harvesting Patient who do not mobilize sufficient cells undergo bone marrow harvest
Patients receive melphalan IV over 30 minutes on days -2 and -1 Half of the stored PBSCs andor bone marrow is reinfused on day 0 Patients receive sargramostim GM-CSF daily beginning on day 0 and continuing until blood counts recover Patients with primary systemic amyloidosis who are not responding to or are unable to tolerate treatment do not proceed to the second course of therapy
Within 4-6 weeks after receiving melphalan patients receive oral busulfan on days -8 to -5 followed by cyclophosphamide IV continuously on days -4 and -3 The remaining half of PBSCs andor bone marrow is reinfused on day 0 Patients receive GM-CSF daily beginning on day 0 and continuing until blood counts recover
Within 4-12 weeks after receiving the second course of high-dose chemotherapy multiple myeloma patients receive maintenance therapy consisting of interferon alfa SC 3 days a week after blood counts recover
Patients are followed every 3 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL Approximately 60-75 patients 25 for responsive disease stratum 25 for refractory or relapsed disease stratum and 10-25 for primary systemic amyloidosis stratum will be accrued for this study within 3 years
Determine the response rate in patients with multiple myeloma or primary systemic amyloidosis treated with high-dose chemotherapy with autologous hematopoietic stem cell support
Determine the toxicity of this regimen in these patients
Determine the disease-free survival and overall survival of patients with multiple myeloma treated with this regimen
OUTLINE Patients are stratified according to disease response to prior treatment responsive vs refractory or relapsed and diagnosis multiple myeloma vs primary systemic amyloidosis
Following a course of induction chemotherapy patients receive filgrastim G-CSF subcutaneously SC daily until the completion of peripheral blood stem cell PBSC harvesting Patient who do not mobilize sufficient cells undergo bone marrow harvest
Patients receive melphalan IV over 30 minutes on days -2 and -1 Half of the stored PBSCs andor bone marrow is reinfused on day 0 Patients receive sargramostim GM-CSF daily beginning on day 0 and continuing until blood counts recover Patients with primary systemic amyloidosis who are not responding to or are unable to tolerate treatment do not proceed to the second course of therapy
Within 4-6 weeks after receiving melphalan patients receive oral busulfan on days -8 to -5 followed by cyclophosphamide IV continuously on days -4 and -3 The remaining half of PBSCs andor bone marrow is reinfused on day 0 Patients receive GM-CSF daily beginning on day 0 and continuing until blood counts recover
Within 4-12 weeks after receiving the second course of high-dose chemotherapy multiple myeloma patients receive maintenance therapy consisting of interferon alfa SC 3 days a week after blood counts recover
Patients are followed every 3 months for 1 year and then annually for 5 years
PROJECTED ACCRUAL Approximately 60-75 patients 25 for responsive disease stratum 25 for refractory or relapsed disease stratum and 10-25 for primary systemic amyloidosis stratum 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 |
|---|---|---|---|
| NCI-G00-1882 | None | None | None |
| CPMC-IRB-7328 | None | None | None |
| CPMC-CAMP-009 | None | None | None |