Myelodysplastic Syndromes
Conditions
Keywords
MDS
Brief summary
This registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving Vidaza, and will provide unique insights into the management of myelodysplastic syndromes (MDS) and other hematological disorders and the impact of these disorders on patients.
Interventions
DRUGAzacitidine
Physician's discretion
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient who is deemed appropriate for treatment with Vidaza® by his or her clinician, but who has not already started receiving Vidaza® treatment. * Patient who is able to read and speak English. * Patient who is willing and able to provide informed consent. * Patient who agrees to complete patient assessment questionnaires.
Exclusion criteria
* Patients who are currently being treated with Vidaza®. * Patients who are concurrently participating in a clinical trial. * Patients unwilling or unable to complete the baseline and follow-up questionnaires. * Patients who are deemed inappropriate for treatment with Vidaza®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vidaza usage | Approximately 4 years | Describe current usage patterns for Vidaza in the community |
| Concomitant care and treatment | Approximately 4 years | Document common concomitant care procedures and treatments used in conjnction wtih Vidaza |
| Duration and number of cycles | Approximately 4 years | Correlate duration and number of Vidaza treatment cycles with clinical response as defined by 2006 International Working Group for Myeleodysplastic Syndrome |
| Publication | Approximately 4 years | Produce publications to support further clinical development and disseminate information on treatment best practices |
Countries
United States
Outcome results
None listed