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First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms (LUNIS)

6. august 2026 oppdatert av: Bristol-Myers Squibb

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

190

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

  • Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Telefonnummer: 855-907-3286
  • E-post: Clinical.Trials@bms.com

Studiesteder

  • Tyskland
      • Mainz, Tyskland
        • Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
First-Line Luspatercept
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Legemiddel: Luspatercept
I henhold til produktetiketten

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Tidsramme: Up to Week 24
Up to Week 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
Tidsramme: Up to Week 48
Up to Week 48
Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks
Tidsramme: Up to Week 48
Up to Week 48
Mean change from baseline in hemoglobin concentration
Tidsramme: 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.
Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
Percentage of participants with hemoglobin increase of at least 1.5 g/dl from baseline
Tidsramme: 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.
Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
Percentage of participants achieving >50% reduction in transfusion burden compared with baseline
Tidsramme: Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
Time from first luspatercept administration to first on-treatment red blood cell transfusion.
Tidsramme: Up to 2-years
Up to 2-years
Time to red blood cell transfusion independence for at least 8 consecutive weeks
Tidsramme: Up to Week 24
Up to Week 24
Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 56 consecutive days.
Tidsramme: Up to 2-years
Up to 2-years
Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 84 consecutive days.
Tidsramme: Up to 2-years
Up to 2-years
Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 112 consecutive days.
Tidsramme: Up to 2-years
Up to 2-years
Percentage of participants achieving hematologic improvement-erythroid response according to International Working Group (IWG) 2006 criteria
Tidsramme: 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
Up to Week 48
Number of participants with adverse events
Tidsramme: Up to 2-years
Up to 2-years
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)
Tidsramme: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
Change from baseline in health-related quality of life assessed by Quality of Life in Myelodysplasia Scale (QUALMS)
Tidsramme: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Etterforskere

  • Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

24. august 2026

Primær fullføring (Antatt)

31. august 2030

Studiet fullført (Antatt)

31. august 2030

Datoer for studieregistrering

Først innsendt

13. juli 2026

Først innsendt som oppfylte QC-kriteriene

6. august 2026

Først lagt ut (Faktiske)

7. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CA056-1175

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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