Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma
MM2011
1 other identifier
observational
196
1 country
1
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 (limited/extensive) will be evaluated as cumulative incidences. Univariate and multivariate analysis will be calculated for the transplant-related and patient-related characteristics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 26, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJuly 11, 2013
July 1, 2013
1.3 years
September 23, 2011
July 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival
1 year
Event-free survival
1 year
Eligibility Criteria
Multiple Myeloma patients
You may qualify if:
- Multiple myeloma patients treated with allogeneic bone marrow transplantation from unrelated donors (from 2000 to 2009: Centri Trapianto GITMO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
A.O.U.San Giovanni Battista di Torino
Torino, 10126, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benedetto Bruno, Dr
A.O.U.San Giovanni Battista di Torino
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
September 23, 2011
First Posted
September 26, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
July 11, 2013
Record last verified: 2013-07