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

NCT ID: NCT06045689

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myelodysplastic Syndromes

Keywords

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Luspatercept Transfusion dependent ACE-536 Anemia Blood Transfusion Red Blood Cell Transfusion Myelodysplastic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: erythropoiesis-stimulating agents (ESA) naïve

Group Type EXPERIMENTAL

Luspatercept

Intervention Type DRUG

Specified dose on specified days.

Cohort 2: ESA relapsed or refractory

Group Type EXPERIMENTAL

Luspatercept

Intervention Type DRUG

Specified dose on specified days.

Interventions

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Luspatercept

Specified dose on specified days.

Intervention Type DRUG

Other Intervention Names

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BMS-986346 ACE-536 REBLOZYL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0051

Los Alamitos, California, United States

Site Status

Local Institution - 0033

New Haven, Connecticut, United States

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Local Institution - 0055

St. Petersburg, Florida, United States

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Local Institution - 0056

Wellington, Florida, United States

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Local Institution - 0020

Kansas City, Kansas, United States

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Local Institution - 0025

Paducah, Kentucky, United States

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Local Institution - 0011

Detroit, Michigan, United States

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Local Institution - 0059

St Louis, Missouri, United States

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Local Institution - 0058

Morristown, New Jersey, United States

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Local Institution - 0032

New York, New York, United States

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Local Institution - 0054

Eugene, Oregon, United States

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Local Institution - 0036

Pittsburgh, Pennsylvania, United States

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Local Institution - 0043

Amarillo, Texas, United States

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Local Institution - 0022

Huntsville, Texas, United States

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Local Institution - 0031

Wheeling, West Virginia, United States

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Local Institution - 0003

Milwaukee, Wisconsin, United States

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Local Institution - 0016

Leuven, Vlaams Brabant, Belgium

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Local Institution - 0008

Roeselare, West-Vlaanderen, Belgium

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Local Institution - 0023

Prague, Praha, Hlavní Mesto, Czechia

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Local Institution - 0004

Prague, Praha, Hlavní Mesto, Czechia

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Local Institution - 0041

Nice, Alpes-Maritimes, France

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Local Institution - 0001

Poitiers, Vienne, France

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Local Institution - 0026

Angers, , France

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Local Institution - 0007

Grenoble, , France

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Local Institution - 0046

Paris, , France

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Local Institution - 0053

Pierre-Bénite, , France

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Local Institution - 0044

Tour Cedex01, , France

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Local Institution - 0013

München, Bavaria, Germany

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Local Institution - 0040

Hanover, Lower Saxony, Germany

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Local Institution - 0009

Leipzig, Saxony, Germany

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Local Institution - 0021

Reggio Calabria, Calabria, Italy

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Local Institution - 0062

Napoli, Campania, Italy

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Local Institution - 0050

Rome, Lazio, Italy

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Local Institution - 0015

Pavia, Lombardy, Italy

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Local Institution - 0029

Rozzano (MI), Milano, Italy

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Local Institution - 0014

Novara, Piedmont, Italy

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Local Institution - 0045

Turin, Piedmont, Italy

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Local Institution - 0024

Florence, Tuscany, Italy

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Local Institution - 0049

Lódz, Lódzkie, Poland

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Local Institution - 0010

Warsaw, Masovian Voivodeship, Poland

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Local Institution - 0034

Katowice, , Poland

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Local Institution - 0035

Wałbrzych, , Poland

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Local Institution - 0047

San Juan, , Puerto Rico

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Local Institution - 0017

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Local Institution - 0005

Barcelona, , Spain

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Local Institution - 0052

Barcelona, , Spain

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Local Institution - 0039

Granada, , Spain

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Local Institution - 0038

Madrid, , Spain

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Local Institution - 0027

Ourense, , Spain

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Local Institution - 0028

Salamanca, , Spain

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Local Institution - 0018

Valencia, , Spain

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Local Institution - 0063

Valencia, , Spain

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Countries

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United States Belgium Czechia France Germany Italy Poland Puerto Rico Spain

Related Links

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Other Identifiers

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CA056-1060

Identifier Type: -

Identifier Source: org_study_id