enalidomide for Myelodysplastic Syndromes: Efficacy, Safety, Cardiac Changes, and Quality of Life (QoL-ESC RevMDS) - QoL-ESC RevMDS

Conditions: ow or Intermediate-1 IPSS risk MDS with del(5q)as a single or combined cytogenetic abnormality and with anemia
MedDRA version: 9.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disorders

Registration Number: EUCTR2008-000547-34-IT

Lead Sponsor: ASSOCIAZIONE QOL-ONE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Primary MDS
2.Age ≥ 18 years
3.Hb < 10 g/dL
4.del(5q) as a single or associated (del(5q) +1 or more) bone marrow cytogenetic abnormality
5.Low or Int-1 IPSS risk
6.No evidence of other causes of anemia
7.Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Secondary MDS or evolving from prior hematological malignancies
2.Intermediate-2 or High IPSS risk MDS
3.Absolute neutrophil counts (ANC) < 500 cells/mm3
4.Platelet counts < 50,000/mm3
5.Contemporary epoetin treatment (epoetin treatment must be interrupted 4 months prior to screening)
6.Prior chemotherapy
7.Creatinine clearance < 60 ml/min
8.Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) and serum direct bilirubin > 2.0 mg/dL
9.Cardiac arrythmias.
10.Thrombophilia or prior thomboembolic events in the absence of proper prophylactic treatment.
11.Pregnancy or inadequate birth control in females of childbearing potential.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate<br>1.changes in quality of life in MDS patients undergoing treatment with lenalidomide<br>2.safety of Lenalidomide in patients with MDS.;Secondary Objective: To evaluate in MDS patients<br>1.the effect of lenalidomide on cardiac remodelling and its correlation with erythroid response in anemic patients with 5q-, low or intermediate-1 risk MDS<br>2.the efficacy of Lenalidomide in terms of response (response / no response) for the treatment of anemia in patients with MDS. <br>3.variations in hemoglobin levels, in the number of monthly transfusions, in platelet and absolute neutrophil counts (ANC) during treatment.<br>4.cytogenetic and molecular responses.;Primary end point(s): 1.Changes in quality of life (QoL-E) scores in the patients undergoing treatment.<br>2.The frequency of adverse events.

Secondary Outcome Measures