NCT06581055

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

August 29, 2024

Last Update Submit

October 7, 2024

Conditions

Myelodysplastic Syndromes (MDS)

Keywords

Myelodysplastic syndromes (MDS)

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Luspatercept

Adult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536).

Drug: Luspatercept

Epoetin alfa

Adult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536).

Drug: Epoetin Alfa

Interventions

LuspaterceptDRUG

As per COMMANDS Trial (NCT03682536) study protocol

Luspatercept
Epoetin AlfaDRUG

As per COMMANDS Trial (NCT03682536) study protocol

Epoetin alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital (NTUH)

Taipei, 10040, Taiwan

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

luspaterceptEpoetin Alfa

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2024

First Posted

August 30, 2024

Study Start

November 30, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)