Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004181
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2000-01-21
Brief Title:
Bone Marrow Transplantation in Treating Patients With Multiple Myeloma Chronic Phase Chronic Myelogenous Leukemia or Agnogenic Myeloid Metaplasia
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-06
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 Bone marrow transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of allogeneic bone marrow transplantation in treating patients who have multiple myeloma chronic phase chronic myelogenous leukemia or agnogenic myeloid metaplasia
PURPOSE Phase II trial to study the effectiveness of allogeneic bone marrow transplantation in treating patients who have multiple myeloma chronic phase chronic myelogenous leukemia or agnogenic myeloid metaplasia
Detailed Description:
OBJECTIVES
Determine the efficacy of allogeneic bone marrow transplantation BMT following high-dose cyclophosphamide and total body irradiation in patients with multiple myeloma agnogenic myeloid metaplasia or chronic myelogenous leukemia in first or second chronic phase
Determine the efficacy of BMT following busulfan and cyclophosphamide in these patients
Determine the toxic effects of these preparative regimens in these patients
OUTLINE Patients are stratified by remission first vs second vs third
Patients who have not undergone prior radiotherapy receive cyclophosphamide IV on days -6 and -5 and then undergo total body irradiation twice a day on days -4 to -1 Allogeneic bone marrow is infused on day 0
Patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7 to -4 or -6 to -3 and cyclophosphamide IV over 2 hours on days -3 and -2 Allogeneic bone marrow is infused on day 0
Patients are followed at days 30 and 90 at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 2 years
Determine the efficacy of allogeneic bone marrow transplantation BMT following high-dose cyclophosphamide and total body irradiation in patients with multiple myeloma agnogenic myeloid metaplasia or chronic myelogenous leukemia in first or second chronic phase
Determine the efficacy of BMT following busulfan and cyclophosphamide in these patients
Determine the toxic effects of these preparative regimens in these patients
OUTLINE Patients are stratified by remission first vs second vs third
Patients who have not undergone prior radiotherapy receive cyclophosphamide IV on days -6 and -5 and then undergo total body irradiation twice a day on days -4 to -1 Allogeneic bone marrow is infused on day 0
Patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7 to -4 or -6 to -3 and cyclophosphamide IV over 2 hours on days -3 and -2 Allogeneic bone marrow is infused on day 0
Patients are followed at days 30 and 90 at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 2 years
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-G99-1639 | None | None | None |
| NU-92H3T | None | None | None |