IMMUNOPHENOTYPE ROLE IN THE EVALUATION OF CLINICAL RESPONSE

• Conditions: Multiple Myeloma; Post Allografting

• Registration Number: NCT02023671
• Lead Sponsor: Azienda Ospedaliera San Giovanni Battista

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-24
• Study First Submitted QC: 2013-12-24
• Last Update Submitted: 2013-12-24
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years
Event free survival	5 years