A Study to Evaluate Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Patients With Lower-Risk Myelodysplastic Syndromes Treated With Luspatercept

NCT ID: NCT07075406

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-08-01

Brief Summary

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The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes

Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants receiving luspatercept treatment

Luspatercept

Intervention Type DRUG

According to product label

Interventions

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Luspatercept

According to product label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of primary myelodysplastic syndromes (MDS) with lower-risk status as measured by the International Prognostic Scoring System (IPSS) or the Revised International Prognostic Scoring System (IPSS-R) at the time of diagnosis

* IPSS risk level: low, intermediate-1 (level-1 risk)
* IPSS-R risk level: very low, low, intermediate
* Initiated luspatercept for treatment of Lower-Risk (LR)-MDS after the initial availability in each country of interest

* US: after April 2020
* Germany: after June 2020
* Spain: after June 2020
* France: after June 202
* Canada: after February 2021
* The participant has a potential follow-up of at least 6 months from the index date (except death)
* The participant is aged 18 years or older at the index date
* The participant has a complete medical record or history for at least 12 months before the index date (or up to the date of initial LR-MDS diagnosis if duration between initial diagnosis and index date is less than 12 months)

Exclusion Criteria

* Received luspatercept as part of a clinical trial
* The participant has evidence of other malignant neoplasms prior to diagnosis of MDS, except disease free for ≥ 5 years at time of MDS diagnosis, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (stage T1a or T1b)
* The participant has a history of Acute Myeloid Leukemia prior to MDS diagnosis
* The participant has participated in clinical trials for specific treatments related to treatment of MDS
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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RTI Health Solutions

Research Triangle Park, North Carolina, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA056-1043

Identifier Type: -

Identifier Source: org_study_id

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