IMMUNOPHENOTYPE ROLE IN THE EVALUATION OF CLINICAL RESPONSE

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Myeloma; Post Allografting

• Study Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with multiple myeloma

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Event free survival	5 years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Giovanni Battista

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: December 24, 2013
• First Submitted That Met QC Criteria: December 24, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma
• Other Study ID Numbers: MM-EMD-2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No