A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes Who Discontinued Treatment With Luspatercept or Epoetin Alfa and the COMMANDS Trial
Overview
- Phase
- Not Applicable
- Intervention
- Luspatercept
- Conditions
- Myelodysplastic Syndromes (MDS)
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Participant treatment patterns: Reason for treatment administration
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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 exclusion criteria for this study.
Arms & Interventions
Luspatercept
Adult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536).
Intervention: Luspatercept
Epoetin alfa
Adult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536).
Intervention: Epoetin Alfa
Outcomes
Primary Outcomes
Participant treatment patterns: Reason for treatment administration
Time Frame: Up to 24 months
Participant treatment patterns: Time to next line of therapy (LoT)
Time Frame: Up to 24 months
Participant treatment patterns: Reason for treatment discontinuation
Time Frame: Up to 24 months
Participant treatment patterns: Type of concomitant medications received
Time Frame: Up to 24 months
Participant treatment patterns: Type of treatment received
Time Frame: Up to 24 months
Participant treatment patterns: Duration of treatment received
Time Frame: Up to 24 months
Participant treatment patterns: Dosage of treatment received
Time Frame: Up to 24 months
Participant treatment patterns: Dosing route of treatment administration
Time Frame: Up to 24 months
Participant treatment patterns: Start and end dates of concomitant medications received
Time Frame: Up to 24 months
Secondary Outcomes
- 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)
- Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018(Up to 24 months)
- 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)