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OpenTrials
Completed

NCT Number: NCT07075406

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RTI Health Solutions

Research Triangle Park, North Carolina, 27709-2194, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Luspatercept

Drug

According to product label

Primary outcomes

  1. Participant baseline demographics

    Time frame: Baseline

  2. Participant baseline clinical characteristics

    Time frame: Baseline

  3. Participant treatment history

    Time frame: Baseline

Secondary outcomes

  1. Number of participants receiving myelodysplastic syndromes (MDS) -directed treatment modalities

    Time frame: Up to 12 months

    MDS-directed treatment modalities include:

    • Therapies for treatment of anemia include
    • Erythropoietin-stimulating agents (ESAs)
    • Granulocyte-colony stimulating factors (G-CSFs
    • Immunosuppressant/Immunomodulatory agents
    • Hypomethylating agents
    • Erythroid maturation agent
    • Other MDS-directed therapies
    • Other supportive care therapies
    • Antibiotic therapy
    • Iron chelation therapy
    • Nutritional support
  2. Systemic therapy agent or combination of agents received by participants

    Time frame: Up to 12 months

  3. Treating clinicians' rationale for prescribing treatment(s)

    Time frame: Up to 12 months

  4. Time to treatment discontinuation

    Time frame: Up to 12 months

  5. Duration of treatment

    Time frame: Up to 12 months

  6. Reason(s) for treatment discontinuation

    Time frame: Up to 12 months

  7. Treatment dosing characteristics

    Time frame: Up to 12 months

    Dosage characteristics includes:

    • Daily dose at treatment initiation
    • Dosing frequency
    • Dose modifications
    • Reason(s) for dose modification
    • Dose and dosing frequency at treatment discontinuation
  8. Sequence of treatments prescribed to participants

    Time frame: Up to 12 months

  9. Number and proportion of participants who received stem-cell transplant

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-world Utilization Patterns, Clinical Outcomes, and HCRU in Lower-risk MDS Patients Treated With Luspatercept: A Multinational Medical Record Review Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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