Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma

NCT ID: NCT01440556

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma Allogeneic Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Multiple myeloma patients treated with allogeneic bone marrow transplantation from unrelated donors (from 2000 to 2009: Centri Trapianto GITMO)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera San Giovanni Battista

OTHER

Sponsor Role lead

Responsible Party

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Benedetto Bruno

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benedetto Bruno, Dr

Role: PRINCIPAL_INVESTIGATOR

A.O.U.San Giovanni Battista di Torino

Locations

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A.O.U.San Giovanni Battista di Torino

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IBMDR-MM-2011

Identifier Type: -

Identifier Source: org_study_id

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