A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

NCT06045689 · tracked via the Priya Life Science Spain tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2023-10-05

Last updated

2026-06-15

Condition(s) studied

Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Luspatercept →

Luspatercept: Specified dose on specified days.

Study summary

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. * Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. * Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: * Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. * Participant has had a prior allogeneic or autologous stem cell transplant. * Participant has known history or diagnosis of AML. * Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24 — Up to week 24

Trial sites (52)

Facility	City	Region
Local Institution - 0051	Los Alamitos	California
Local Institution - 0033	New Haven	Connecticut
Local Institution - 0055	St. Petersburg	Florida
Local Institution - 0056	Wellington	Florida
Local Institution - 0020	Kansas City	Kansas
Local Institution - 0025	Paducah	Kentucky
Local Institution - 0011	Detroit	Michigan
Local Institution - 0059	St Louis	Missouri
Local Institution - 0058	Morristown	New Jersey
Local Institution - 0032	New York	New York
Local Institution - 0054	Eugene	Oregon
Local Institution - 0036	Pittsburgh	Pennsylvania
Local Institution - 0043	Amarillo	Texas
Local Institution - 0022	Huntsville	Texas
Local Institution - 0031	Wheeling	West Virginia
Local Institution - 0003	Milwaukee	Wisconsin
Local Institution - 0016	Leuven	Vlaams Brabant
Local Institution - 0008	Roeselare	West-Vlaanderen
Local Institution - 0023	Prague	Praha, Hlavní Mesto
Local Institution - 0004	Prague	Praha, Hlavní Mesto
Local Institution - 0041	Nice	Alpes-Maritimes
Local Institution - 0001	Poitiers	Vienne
Local Institution - 0026	Angers	France
Local Institution - 0007	Grenoble	France
Local Institution - 0046	Paris	France
Local Institution - 0053	Pierre-Bénite	France
Local Institution - 0044	Tour Cedex01	France
Local Institution - 0013	München	Bavaria
Local Institution - 0040	Hanover	Lower Saxony
Local Institution - 0009	Leipzig	Saxony
Local Institution - 0021	Reggio Calabria	Calabria
Local Institution - 0062	Naples	Campania
Local Institution - 0050	Rome	Lazio
Local Institution - 0015	Pavia	Lombardy
Local Institution - 0029	Rozzano (MI)	Milano
Local Institution - 0014	Novara	Piedmont
Local Institution - 0045	Turin	Piedmont
Local Institution - 0024	Florence	Tuscany
Local Institution - 0049	Lódz	Lódzkie
Local Institution - 0010	Warsaw	Masovian Voivodeship

+ 12 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06045689 on ClinicalTrials.gov ↗ ← All trials in Spain