Multiple Myeloma Clinical Trial
| Verified date | December 2013 |
| Source | Azienda Ospedaliera San Giovanni Battista |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 70 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Ospedaliera San Giovanni Battista |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | 5 years | No | |
| Primary | Event free survival | 5 years | No |
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