First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms (LUNIS)
6 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
190
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: First line of the email MUST contain NCT # and Site #.
Studie Contact Back-up
- Naam: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefoonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studie Locaties
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Mainz, Duitsland
- Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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.
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Volgens productlabel
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Tijdsspanne: Up to Week 24
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Up to Week 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
Tijdsspanne: Up to Week 48
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Up to Week 48
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Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks
Tijdsspanne: Up to Week 48
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Up to Week 48
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Mean change from baseline in hemoglobin concentration
Tijdsspanne: Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Hemoglobin concentration (g/dL) measured during routine clinical practice.
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Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Percentage of participants with hemoglobin increase of at least 1.5 g/dl from baseline
Tijdsspanne: Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Hemoglobin concentration (g/dL) measured during routine clinical practice.
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Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Percentage of participants achieving >50% reduction in transfusion burden compared with baseline
Tijdsspanne: Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)
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Time from first luspatercept administration to first on-treatment red blood cell transfusion.
Tijdsspanne: Up to 2-years
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Up to 2-years
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Time to red blood cell transfusion independence for at least 8 consecutive weeks
Tijdsspanne: Up to Week 24
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Up to Week 24
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Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 56 consecutive days.
Tijdsspanne: Up to 2-years
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Up to 2-years
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Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 84 consecutive days.
Tijdsspanne: Up to 2-years
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Up to 2-years
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Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 112 consecutive days.
Tijdsspanne: Up to 2-years
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Up to 2-years
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Percentage of participants achieving hematologic improvement-erythroid response according to International Working Group (IWG) 2006 criteria
Tijdsspanne: Up to Week 48
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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
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Up to Week 48
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Number of participants with adverse events
Tijdsspanne: Up to 2-years
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Up to 2-years
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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)
Tijdsspanne: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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Change from baseline in health-related quality of life assessed by Quality of Life in Myelodysplasia Scale (QUALMS)
Tijdsspanne: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Bristol-Myers Squibb, Bristol-Myers Squibb
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
24 augustus 2026
Primaire voltooiing (Geschat)
31 augustus 2030
Studie voltooiing (Geschat)
31 augustus 2030
Studieregistratiedata
Eerst ingediend
13 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
6 augustus 2026
Eerst geplaatst (Werkelijk)
7 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
6 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CA056-1175
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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