MYELODISPLASTIC SYNDROME MedDRA version: 14.1 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: EPREX*IV FL 4000UI 1ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin
Concentration unit: IU international unit(s)
Concentration number: 40000-
Trade Name
Sponsors
FISM ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? OVER 18 years ? Diagnosis confirmed from BONE MARROW biopsy AND ASPIRATE MEDULLARY ? IPSS I OR II ? INFERIOR value OF Hb to 11 g/dl. ? Seric Value of rEPO =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Myelodisplastic Syndrome with excess of blasts (RAEB). ? IPSS Intermediate-2 or high ? Forecast of allogenic bone marrow transplant within 1 year from the diagnosis ? Renal Insufficiency with advanced value of creatininemia to 3 times the normal limit. ? Chronic Epatopatia with advanced value of bilirubinemia to 3 times the normal limit and/or advanced values of AST or STOP or ALP to 5 times the normal limit. ? Other serious pathology or Presence neoplasia with life expectancy of inferior to 1 year . ? Presence of neurological or psychiatric disorder ? Allergy/intolerance to drugs employs. ? Pregnant Women. ? age < 18 years. ? HIV+.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confront after 4 months of therapy the obtained eritroide RESPONSE with the conventional therapy with single rEPO to 40.000 U/week doses with that one obtained with the therapy of association between the same doses of rEPO and the therapy differentiating with acidio 13-cis-retinoico + DIIDROXILATE D3 vitamin.;Secondary Objective: TO EVALUATED if, in the patients who have not obtained a eritroide RESPONSE to the 4ST month of therapy, the increase of dose of rEPO to 80.000 U/settimana allows to obtain an increment of RESPONSE estimated to the 8ST month. ? TO EVALUATED THE difference of duration of the obtained eritroide RESPONSE with therapy rEPO ALONE regarding that one obtained with rEPO associated to therapy differentiating with 13-cis-retinoico acid + diidroXilatED D3 vitamin. ? TO EVALUATED the existing relations between eritroide RESPONSE and clinician-biological parameters of debut which AMOUNT of the anemia, TYPE of MDS, SIERIC dosage of EPO etc ? TO EVALUATED the induced improvement of the quality of life from the answer to the therapy. ?TO EVALUATED the percentage of leucemica evolution.;Primary end point(s): ERYTROID RESPONSE | — |
Countries
Italy
Outcome results
None listed