Trial Information

QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME

In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often
represents the principal cause of symptoms which negatively influence quality of life
(QoL). Moreover anemia has been associated with increased cardiac disease which, in older
patients, may aggravate pre-existing conditions such as congestive heart failure. Patients
with MDS often require red blood cell transfusions that further deteriorate patients'
perception of well-being. This is an 18-month prospective observational investigation about
the Quality of Life in Myelodysplastic patients with the aim to evaluate the correlation
between hemoglobin (Hb) value and QoL and to compare the MDS patient's self-assessed QoL per
physician's assessment. One hundred and fifty consecutive MDS patients at diagnosis and at
least one with cytopenia - low level of hemoglobin or low level of neutrophils (a type of
white blood cells that fights against infection) or low level of platelets (irregularly
shaped cells found in blood that help prevent bleeding) - will be included in the
evaluation. Demographic and disease-specific data will be collected and QoL will be
evaluated by a specific questionnaire named QoL-E which will be completed both by patients
and respective physicians. Study visits will be performed monthly until week 12; the
subsequent visits will be performed at 6, 12 and 18 months. No Serious Adverse Event will be
collected during the study, only adverse reaction to any Janssen-Cilag drug should be
reported. This information may be important to optimize treatment according to patients'
preferences and expectations, to detect functional complications, as well as to improve
communication between patients and caregivers. Observational study - No study drug was
administered.