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Sponsor decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luspatercept | Adult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536). |
| |
| Epoetin alfa | Adult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luspatercept | Drug | As per COMMANDS Trial (NCT03682536) study protocol |
| |
| Measure | Description | 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
• There are no exclusion criteria for this study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital (NTUH) | Taipei | 10040 | Taiwan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000621232 | luspatercept |
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Epoetin Alfa |
| Drug |
As per COMMANDS Trial (NCT03682536) study protocol |
|
| Up to 24 months |
| Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018 | IWG 2028 criteria:
| 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 |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |