Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01440556
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2011-09-23
Brief Title:
Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma
Sponsor:
Azienda Ospedaliera San Giovanni Battista
Organization:
Azienda Ospedaliera San Giovanni Battista
Study Overview
Official Title:
Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma a Study From the Italian Bone Marrow Transplantation Donor Registry
Status:
COMPLETED
Status Verified Date:
2013-07
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:
MM2011
Brief Summary:
Autologous hematopoietic cell transplantation is currently considered the standard therapy of multiple myeloma MM for elegible patients On the contrary despite new developments in transplant procedures and supportive care allogeneic bone marrow transplantation is less commonly used due to high transplant related mortality TRM
No consensus statement about allografting in MM has so far been reached and only a minority of patients undergoing allografting are enrolled in prospective clinical trials
Moreover use of unrelated donors is considerably increased over the time and the recent activity survey of European Group for Blood and Marrow Transplantation EBMT showed that the number of allografts from unrelated donor is higher than that one from HLA-identical siblings in Europe
In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients the investigators plan to conduct a restrospective study through the Italian Bone Marrow Transplantation Registry IBMDR over a period ranging since 2000 to 2009 Data will be collected from the central data management system Promise Project Manager Internet Server used by EBMT and from IBMDR
The aim of the study is to evaluate the role of unrelated donor allograft in multiple myeloma over the last decade and hopefully offer recommendations on patient selection Primary endpoints of the study are a Overall Survival OS from diagnosis and from the allograft b Event-Free-Survival EFS from the allograft Disease response criteria will be defined according to the International Uniform Response Criteria for multiple myeloma Transplant related mortality Graft-Versus-Host-Disease GVHD either acute or chronic limitedextensive will be evaluated as cumulative incidences Univariate and multivariate analysis will be calculated for the transplant-related and patient-related characteristics
No consensus statement about allografting in MM has so far been reached and only a minority of patients undergoing allografting are enrolled in prospective clinical trials
Moreover use of unrelated donors is considerably increased over the time and the recent activity survey of European Group for Blood and Marrow Transplantation EBMT showed that the number of allografts from unrelated donor is higher than that one from HLA-identical siblings in Europe
In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients the investigators plan to conduct a restrospective study through the Italian Bone Marrow Transplantation Registry IBMDR over a period ranging since 2000 to 2009 Data will be collected from the central data management system Promise Project Manager Internet Server used by EBMT and from IBMDR
The aim of the study is to evaluate the role of unrelated donor allograft in multiple myeloma over the last decade and hopefully offer recommendations on patient selection Primary endpoints of the study are a Overall Survival OS from diagnosis and from the allograft b Event-Free-Survival EFS from the allograft Disease response criteria will be defined according to the International Uniform Response Criteria for multiple myeloma Transplant related mortality Graft-Versus-Host-Disease GVHD either acute or chronic limitedextensive will be evaluated as cumulative incidences Univariate and multivariate analysis will be calculated for the transplant-related and patient-related characteristics
Detailed Description:
None
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