A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes
- Registration Number
- NCT06581055
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 86
- 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).
• There are no exclusion criteria for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Epoetin alfa Epoetin Alfa Adult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536). Luspatercept Luspatercept Adult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536).
- Primary Outcome Measures
Name Time Method 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 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: Start and end dates of concomitant medications received Up to 24 months
- Secondary Outcome Measures
Name Time Method Participant clinical characteristics Up to 24 months Participant clinical outcomes: Date and primary cause of death Up to 24 months 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
Trial Locations
- Locations (1)
National Taiwan University Hospital (NTUH)
🇨🇳Taipei, Taiwan