Multiple Myeloma Clinical Trial
Official title:
Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma: a Study From the Italian Bone Marrow Transplantation Donor Registry
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.
n/a
Observational Model: Case Control, Time Perspective: Retrospective
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