Ensayos clínicos

Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Male or female ≥18 years of age
2. Diagnosis of MDS according to World Health Organisation (WHO) criteria confirmed by bone marrow aspirate and biopsy
3. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk MDS
4. Red Blood Cell (RBC) transfusion dependent (i.e. requiring at least 4 units during an 8-week period)
5. Has MDS that is relapsed/refractory to erythropoietic stimulating agent (ESA) treatment
6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 2
7. Able to attend and participate in a 90 minute interview. Must be literate in US-English and verbally fluent in US-English

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

1. Subject has received an investigational drug or used an invasive investigational medical device within 30 days prior to screening or is currently enrolled in an investigational study;
2. Prior history of hematopoietic stem cell transplant;
3. Diagnosed or treated for malignancy other than MDS;
4. Significant difficulty hearing, reading or speaking;
5. Has an uncontrolled psychiatric condition (e.g., schizophrenia, bipolar disorder) or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study or likely to have difficulty participating in a 90 minute interview;
6. Has severe physical, neurological or cognitive deficits that might affect their ability to participate in an interview about their experience of MDS and completion of two questionnaires.