First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms (LUNIS)
6 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
190
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: First line of the email MUST contain NCT # and Site #.
Studera Kontakt Backup
- Namn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-post: Clinical.Trials@bms.com
Studieorter
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Mainz, Tyskland
- Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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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Enligt produktetikett
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Tidsram: Up to Week 24
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Up to Week 24
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
Tidsram: 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
Tidsram: Up to Week 48
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Up to Week 48
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Mean change from baseline in hemoglobin concentration
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
24 augusti 2026
Primärt slutförande (Beräknad)
31 augusti 2030
Avslutad studie (Beräknad)
31 augusti 2030
Studieregistreringsdatum
Först inskickad
13 juli 2026
Först inskickad som uppfyllde QC-kriterierna
6 augusti 2026
Första postat (Faktisk)
7 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CA056-1175
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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