IMMUNOPHENOTYPE ROLE IN THE EVALUATION OF CLINICAL RESPONSE

NCT02023671 | Unknown

• 1 other identifier: MM-EMD-2013
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma; Post Allografting

Outcome Measures

Primary Outcomes (2)

• Overall survival

  5 years

• Event free survival

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with multiple myeloma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera San Giovanni Battista: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 24, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: December 30, 2013

Record last verified: 2013-12