Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003163
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers
Sponsor:
Medical College of Wisconsin
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies
Status:
UNKNOWN
Status Verified Date:
2002-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have multiple myeloma or other B-cell cancers
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have multiple myeloma or other B-cell cancers
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of myeloablative therapy with autologous hematopoietic stem cell transplantation in patients with multiple myeloma and other B-cell malignancies
Determine the efficacy and pretransplantation prognostic factors associated with myeloablative therapy in these patients
Determine engraftment kinetics of granulocytes and platelets as well as blood product transfusion requirements following hematopoietic stem cell transplantation
OUTLINE Patients must have hematopoietic stem cell procurement completed prior to myeloablative therapy Patients receive high dose chemotherapy with autologous hematopoietic stem cell transplantation and supportive care Melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion Peripheral blood stem cells andor bone marrow is reinfused on day 0 Filgrastim G-CSF or sargramostim GM-CSF is administered beginning on day 1 posttransplantation and continuing until blood counts recover
Patients who are not candidates for tandem transplant may receive melphalan plus total body irradiation TBI Melphalan is administered IV on day -4 Total body irradiation is administered three times a day on days -3 and -2 and twice on day -1 At least 4 hours must elapse between each treatment Hematopoietic stem cells are reinfused on day -1 upon completion of TBI or on day 0
If patient is ineligible for melphalan plus TBI the alternative single high dose regimen of melphalan plus cyclophosphamide is administered Melphalan for these patients is given in two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3 and -2 Hematopoietic stem cells are reinfused on day 0
A second transplant may be considered preferably between 3 and 6 months after the first transplant The preferred regimen for the second transplant is melphalan alone or melphalan plus TBI as described above The alternative regimens for the second dose therapy are melphalan alone or melphalan plus cyclophosphamide For patients receiving melphalan alone melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion Hematopoietic stem cells are reinfused on day 0 for both alternative regimens
Patients are followed for response from treatment for a minimum of 4 weeks and then periodically for survival
PROJECTED ACCRUAL A minimum of 10 patients will be accrued for this study
Determine the safety and efficacy of myeloablative therapy with autologous hematopoietic stem cell transplantation in patients with multiple myeloma and other B-cell malignancies
Determine the efficacy and pretransplantation prognostic factors associated with myeloablative therapy in these patients
Determine engraftment kinetics of granulocytes and platelets as well as blood product transfusion requirements following hematopoietic stem cell transplantation
OUTLINE Patients must have hematopoietic stem cell procurement completed prior to myeloablative therapy Patients receive high dose chemotherapy with autologous hematopoietic stem cell transplantation and supportive care Melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion Peripheral blood stem cells andor bone marrow is reinfused on day 0 Filgrastim G-CSF or sargramostim GM-CSF is administered beginning on day 1 posttransplantation and continuing until blood counts recover
Patients who are not candidates for tandem transplant may receive melphalan plus total body irradiation TBI Melphalan is administered IV on day -4 Total body irradiation is administered three times a day on days -3 and -2 and twice on day -1 At least 4 hours must elapse between each treatment Hematopoietic stem cells are reinfused on day -1 upon completion of TBI or on day 0
If patient is ineligible for melphalan plus TBI the alternative single high dose regimen of melphalan plus cyclophosphamide is administered Melphalan for these patients is given in two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3 and -2 Hematopoietic stem cells are reinfused on day 0
A second transplant may be considered preferably between 3 and 6 months after the first transplant The preferred regimen for the second transplant is melphalan alone or melphalan plus TBI as described above The alternative regimens for the second dose therapy are melphalan alone or melphalan plus cyclophosphamide For patients receiving melphalan alone melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion Hematopoietic stem cells are reinfused on day 0 for both alternative regimens
Patients are followed for response from treatment for a minimum of 4 weeks and then periodically for survival
PROJECTED ACCRUAL A minimum of 10 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 |
|---|---|---|---|
| NCI-V97-1368 | None | None | None |
| MCW-96110 | None | None | None |
| MCW-HRRC-29196 | None | None | None |