Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075829
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-01-09
Brief Title:
Stem Cell Transplantation in Individuals With Multiple Myeloma BMT CTN 0102
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
A Trial of Tandem Autologous Stem Cell Transplants - Post Second Autologous Transplant Maintenance Therapy vs Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-myeloablative Allogeneic Stem Cell Transplant for Patients With Multiple Myeloma BMT CTN 0102
Status:
COMPLETED
Status Verified Date:
2017-08
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:
The study is designed as a Phase III multi-center trial of tandem autologous transplants versus the strategy of autologous followed by Human Leukocyte Antigen HLA-matched sibling non-myeloablative allogeneic transplant Study subjects will be biologically assigned to the appropriate arm depending on the availability of an HLA-matched sibling There is a nested randomized phase III trial of observation versus maintenance therapy following the second autologous transplant for patients on the tandem autologous transplant arm
Detailed Description:
Multiple myeloma MM characterized by malignant plasma cell proliferation bone destruction and immunodeficiency is a disease with a median age at diagnosis of approximately 65 years It is responsible for about 1 percent of all cancer-related deaths in Western Countries Conventional treatments with chemotherapy and radiation therapy are non-curative but improve quality of life and duration of survival Attempts to cure myeloma through high-dose therapy followed by autografting or allografting have largely failed due to a combination of relapsed disease or transplant related mortality TRM High-dose therapy with autologous transplantation is safe and has low TRM less than 5 but is associated with a continuing and nearly universal risk of disease progression and relapse Even so autologous transplantation is superior to continued conventional chemotherapy Recent data indicate that tandem autologous transplants are superior to a single procedure Even with this approach patients remain at risk of relapse and additional approaches are needed
DESIGN NARRATIVE
The overall study design is that of biologic assignment based on the availability of an HLA-matched sibling to one of two treatment strategies for MM patients Patients without an HLA-matched sibling will undergo tandem autologous transplants Patients with an HLA-matched sibling will undergo an autologous transplant followed by a non-myeloablative allogeneic transplant In addition the tandem autologous transplant recipients will be randomized to either observation or one year of maintenance therapy to begin following the second autologous transplant The large number of MM patients without an HLA-matched sibling enables us to evaluate the role of maintenance therapy following tandem autologous transplants
DESIGN NARRATIVE
The overall study design is that of biologic assignment based on the availability of an HLA-matched sibling to one of two treatment strategies for MM patients Patients without an HLA-matched sibling will undergo tandem autologous transplants Patients with an HLA-matched sibling will undergo an autologous transplant followed by a non-myeloablative allogeneic transplant In addition the tandem autologous transplant recipients will be randomized to either observation or one year of maintenance therapy to begin following the second autologous transplant The large number of MM patients without an HLA-matched sibling enables us to evaluate the role of maintenance therapy following tandem autologous transplants
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 |
|---|---|---|---|
| 417 | OTHER | NHLBI | None |
| BMT CTN 0102 | OTHER | None | None |
| SUMC-79730 | OTHER | None | None |