Low or Intermediate-1 IPSS risk MDS with del(5q)as a single or combined cytogenetic abnormality and with anemia MedDRA version: 9.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Lenalidomide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
ASSOCIAZIONE QOL-ONE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary MDS 2. Age ≥ 18 years 3. Hb =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Secondary MDS or evolving from prior hematological malignancies 2. Intermediate-2 or High IPSS risk MDS 3. Absolute neutrophil counts (ANC) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate 1. changes in quality of life in MDS patients undergoing treatment with lenalidomide 2. safety of Lenalidomide in patients with MDS.;Secondary Objective: To evaluate in MDS patients 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 2. the efficacy of Lenalidomide in terms of response (response / no response) for the treatment of anemia in patients with MDS. 3. variations in hemoglobin levels, in the number of monthly transfusions, in platelet and absolute neutrophil counts (ANC) during treatment. 4. cytogenetic and molecular responses.;Primary end point(s): 1. Changes in quality of life (QoL-E) scores in the patients undergoing treatment. 2. The frequency of adverse events. | — |
Countries
Italy
Outcome results
None listed