Clinical trial NCT06581055: A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myelodysplastic Syndromes (MDS)
Keywords: Myelodysplastic syndromes (MDS)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult participants with myelodysplastic syndromes who were enrolled in the COMMANDS trial (NCT03682536) and discontinued Luspatercept or Epoetin alfa treatment and discontinued the COMMANDS trial.

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.


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.

Primary outcomes:
measure: Participant treatment patterns: Type of treatment received
timeFrame: Up to 24 months
measure: Participant treatment patterns: Duration of treatment received
timeFrame: Up to 24 months
measure: Participant treatment patterns: Dosage of treatment received
timeFrame: Up to 24 months
measure: Participant treatment patterns: Dosing route of treatment administration
timeFrame: Up to 24 months
measure: Participant treatment patterns: Reason for treatment administration
timeFrame: Up to 24 months
measure: Participant treatment patterns: Time to next line of therapy (LoT)
timeFrame: Up to 24 months
measure: Participant treatment patterns: Reason for treatment discontinuation
timeFrame: Up to 24 months
measure: Participant treatment patterns: Type of concomitant medications received
timeFrame: Up to 24 months
measure: Participant treatment patterns: Start and end dates of concomitant medications received
timeFrame: Up to 24 months
Secondary outcomes:
measure: Participant clinical outcomes: Number of units of red blood cell transfusions received
timeFrame: Up to 24 months
measure: Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category
timeFrame: Up to 24 months
measure: Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018
timeFrame: Up to 24 months
measure: Participant clinical outcomes: Blood test results
timeFrame: Up to 24 months
measure: Participant clinical outcomes: Number of participants that progressed to acute myeloid leukemia (AML) status
timeFrame: Up to 24 months
measure: Number of participants that progressed to high-risk myelodysplastic syndromes (MDS)
timeFrame: Up to 24 months
measure: Participant clinical outcomes: Participant survival status
timeFrame: Up to 24 months
measure: Participant clinical outcomes: Date and primary cause of death
timeFrame: Up to 24 months
measure: Participant clinical characteristics
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: