A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Myelodysplastic Syndromes (MDS)
• Intervention / Treatment: Drug: Luspatercept; Drug: Epoetin Alfa

• Study Type: Observational

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10040
    • National Taiwan University Hospital (NTUH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Luspatercept; Adult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536).	Drug: Luspatercept; As per COMMANDS Trial (NCT03682536) study protocol
Epoetin alfa; Adult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536).	Drug: Epoetin Alfa; As per COMMANDS Trial (NCT03682536) study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Participant treatment patterns: Start and end dates of concomitant medications received	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	Up to 24 months
Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018	IWG 2028 criteria: Non-transfused (0 Red Blood Cells [RBC] in 16 weeks); Low-transfusion burden (3-7 RBCs in 16 weeks in at least 2 transfusion episodes, maximum 3 in 8 weeks); High-transfusion burden (≥8 RBCs in 16 week, ≥4 in 8 weeks)	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
Participant clinical outcomes: Date and primary cause of death		Up to 24 months
Participant clinical characteristics		Up to 24 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Myelodysplastic syndromes (MDS)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia; Hematinics; Epoetin Alfa; Luspatercept
• Other Study ID Numbers: CA056-1083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No