Myelodysplastic Syndromes (MDS)
Conditions
Keywords
Myelodysplastic syndromes (MDS)
Brief summary
This study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records.
Interventions
DRUGLuspatercept
As per COMMANDS Trial (NCT03682536) study protocol
DRUGEpoetin Alfa
As per COMMANDS Trial (NCT03682536) study protocol
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
* Participant was enrolled in and discontinued the COMMANDS trial. * Participant was treated with either luspatercept or epoetin alfa and discontinued treatment while enrolled in the COMMANDS trial. * Participant Patient provides informed consent (only where applicable or required by local regulations).
Exclusion criteria
• There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant treatment patterns: Start and end dates of concomitant medications received | Up to 24 months |
| Participant treatment patterns: Type of treatment received | Up to 24 months |
| Participant treatment patterns: Duration of treatment received | Up to 24 months |
| Participant treatment patterns: Dosage of treatment received | Up to 24 months |
| Participant treatment patterns: Dosing route of treatment administration | Up to 24 months |
| Participant treatment patterns: Reason for treatment administration | Up to 24 months |
| Participant treatment patterns: Time to next line of therapy (LoT) | Up to 24 months |
| Participant treatment patterns: Reason for treatment discontinuation | Up to 24 months |
| Participant treatment patterns: Type of concomitant medications received | Up to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant clinical outcomes: Number of units of red blood cell transfusions received | Up to 24 months | — |
| Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category | Up to 24 months | Category 1: Transfusion dependent (at least 4 units of red blood cell (RBC) with 8 weeks for hemoglobin (Hb) \<9g/dL) Category 2: Transfusion independence (\<4 units of RBC with 8 weeks for Hb \<9 g/dL) |
| Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018 | Up to 24 months | IWG 2028 criteria: 1. Non-transfused (0 Red Blood Cells \[RBC\] in 16 weeks) 2. Low-transfusion burden (3-7 RBCs in 16 weeks in at least 2 transfusion episodes, maximum 3 in 8 weeks) 3. High-transfusion burden (≥8 RBCs in 16 week, ≥4 in 8 weeks) |
| Participant clinical outcomes: Blood test results | Up to 24 months | — |
| Participant clinical outcomes: Number of participants that progressed to acute myeloid leukemia (AML) status | Up to 24 months | — |
| Number of participants that progressed to high-risk myelodysplastic syndromes (MDS) | Up to 24 months | — |
| Participant clinical outcomes: Participant survival status | Up to 24 months | — |
| Participant clinical outcomes: Date and primary cause of death | Up to 24 months | — |
| Participant clinical characteristics | Up to 24 months | — |
Countries
Taiwan
Outcome results
None listed