Overview

This trial is active, not recruiting.

Conditions multiple myeloma, post allografting
Sponsor Azienda Ospedaliera San Giovanni Battista
Start date December 2013
End date December 2014
Trial size 70 participants
Trial identifier NCT02023671, MM-EMD-2013

Summary

The study proposed by SSCVD Allogeneic Stem Cells of this Hospital provides for the collection of a series composed of patients with multiple myeloma undergoing allogeneic stem cell transplants at our center in the period 2000-2011.

This collection is carried out with retrospective investigation , through the review of paper and electronic records and data cards already collected as part of clinical trials conducted by our own Division and approved by the Ethics Committee of Management.

The purpose of data collection is particularly retrospective analysis of the incidence of extramedullary relapse , the response in flow cytometry immunophenotypic and clinical response of the disease , will also be taken into consideration for overall survival ( OS) , event-free survival (EFS) , the cumulative incidence of treatment-related mortality and graft- versus-host disease ( GVHD ), acute and chronic.

The data were processed in a completely anonymous and as provided by law. The results of the study will not result in any diagnostic or therapeutic intervention on patients still alive.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective

Primary Outcomes

Measure
Overall survival
time frame: 5 years
Event free survival
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Adult patients with multiple myeloma undergoing allogeneic stem cell transplantation in the period 2000-2011 at the University Transplant Center of the Division of Hematology. Were taken into account both donor transplants voluntary blood relative. Exclusion Criteria: Patients who died early after allogeneic transplantation (<3 months) in which has not been evaluated disease status. In the evaluation of the response of immunophenotypic disease were excluded from the analysis of bone marrow aspirate samples with low cellularity.

Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Azienda Ospedaliera San Giovanni Battista.