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NCT Number: NCT07752121

First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms

This study will observe adults with lower-risk myelodysplastic neoplasms (MDS) who have anemia requiring regular red blood cell transfusions and who are prescribed first-line luspatercept as part of routine medical care. The study will follow participants for up to 2 years to understand how often treatment leads to periods without transfusions, changes in hemoglobin levels, health-related quality of life, and safety outcomes. Information on treatment use and outcomes in routine clinical practice in Germany will also be collected.

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Key information

Conditions

Myelodysplastic Neoplasms Anemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie

Mainz, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females ≥18 years of age at enrollment.
  • Documented diagnosis of myelodysplastic neoplasms according to World Health Organisation (WHO) 2022 or WHO 2016 classification meeting International Prognostic Scoring System-Revised (IPSS-R) criteria for very low-, low-, or intermediate-risk disease.
  • Documented red blood cell transfusion dependence of ≥2 units of red blood cells within the 8 weeks preceding Day 1 treatment initiation.
  • First-line treatment based on the approved luspatercept label and decision for treatment with luspatercept as assessed by the treating physician prior to study participation
  • Provision of written informed consent.

Exclusion criteria

  • Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC).
  • Parallel participation in an interventional clinical trial (except follow-up phase as specified in protocol).

Patients who have completed their participation in an interventional clinical trial or who are not receiving any study drug anymore and who are only in the follow-up phase can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.

  • Concurrent malignancy requiring treatment.

Treatment and study plan

Luspatercept

Drug

As per product label

Primary outcomes

  1. Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks

    Time frame: Up to Week 24

Secondary outcomes

  1. Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks

    Time frame: Up to Week 48

  2. Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks

    Time frame: Up to Week 48

  3. Mean change from baseline in hemoglobin concentration

    Time frame: Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)

    Hemoglobin concentration (g/dL) measured during routine clinical practice.

  4. Percentage of participants with hemoglobin increase of at least 1.5 g/dl from baseline

    Time frame: Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)

    Hemoglobin concentration (g/dL) measured during routine clinical practice.

  5. Percentage of participants achieving >50% reduction in transfusion burden compared with baseline

    Time frame: Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)

  6. Time from first luspatercept administration to first on-treatment red blood cell transfusion.

    Time frame: Up to 2-years

  7. Time to red blood cell transfusion independence for at least 8 consecutive weeks

    Time frame: Up to Week 24

  8. Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 56 consecutive days.

    Time frame: Up to 2-years

  9. Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 84 consecutive days.

    Time frame: Up to 2-years

  10. Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 112 consecutive days.

    Time frame: Up to 2-years

  11. Percentage of participants achieving hematologic improvement-erythroid response according to International Working Group (IWG) 2006 criteria

    Time frame: Up to Week 48

    Hematologic improvement-erythroid (HI-E) response is defined as an increase in hemoglobin of at least 1.5 g/dL and/or a reduction of at least 4 red blood cell transfusions during an 8-week period compared with the 8 weeks before treatment, sustained over any consecutive 56-day period

  12. Number of participants with adverse events

    Time frame: Up to 2-years

  13. Change from baseline in health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Time frame: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)

  14. Change from baseline in health-related quality of life assessed by Quality of Life in Myelodysplasia Scale (QUALMS)

    Time frame: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Prospective, Multicenter, Non-Interventional Study Assessing First-line Luspatercept in Anemic Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Neoplasms Requiring Red Blood Cell Transfusions

Acronym: LUNIS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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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