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Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma (MM2011)

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ClinicalTrials.gov Identifier: NCT01440556
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Multiple Myeloma Allogeneic Transplantation

Study Design

Study Type : Observational
Actual Enrollment : 196 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma: a Study From the Italian Bone Marrow Transplantation Donor Registry
Study Start Date : October 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
  2. Event-free survival [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple Myeloma patients

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440556

A.O.U.San Giovanni Battista di Torino
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Principal Investigator: Benedetto Bruno, Dr A.O.U.San Giovanni Battista di Torino
More Information

Responsible Party: Benedetto Bruno, Dr, Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier: NCT01440556     History of Changes
Other Study ID Numbers: IBMDR-MM-2011
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Benedetto Bruno, Azienda Ospedaliera San Giovanni Battista:
Allogeneic bone marrow transplantation
Multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases