Myelodysplastic Syndromes
Conditions
Keywords
Lower Risk Myelodysplastic Syndromes
Brief summary
The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China
Interventions
DRUGLuspatercept
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants ≥ 18 years of age. * Documented diagnosis of no del(5q) MDS that meets lower-risk Myelodysplastic Syndromes (MDS) classification. (Diagnosis criteria and risk classification criteria are based on clinical practice) * Patients who were erythropoiesis-stimulating agent (ESA)-naïve have received luspatercept monotherapy at least 2 cycles regardless of RS status. * Historical documentation of anemia before luspatercept treatment.
Exclusion criteria
* Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis. * Received stem cell transplant prior to luspatercept treatment initiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant red blood cell transfusion independence | Up to 12-weeks |
| Participants mean hemoglobin (Hb) increase ≥1.5 g/dL | Up to 12-weeks |
Secondary
| Measure | Time frame |
|---|---|
| Participant transfusion independence and increase in hemoglobin (Hb) | Up to 48 weeks |
| Duration of luspatercept monotherapy treatment | Up to 48 weeks |
| Health Care Resource Utilization (HCRU) | Up to 48 weeks |
Countries
China
Contacts
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed