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

NCT06045689 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CA056-1060
• Study Type: interventional
• Target: 106
• Locations: 9 countries
• Sites: 52

Brief 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.

Conditions

Myelodysplastic Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (18)

• Number of participants with a mean change in total RBC units transfused over a fixed 16-week period from Week 9 to Week 24 and from Week 33 to Week 48

  Up to week 48

• Number of participants who have a time from first dose to first onset of RBC-TI ≥ 8-, 12-, and 16-weeks from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT

  Up to 2 years

• Number of participants who achieve RBC-TI over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 to EOT

  Up to 2 years

• Number of participants with a maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period from Week 1 to Week 24 and from Week 1 to EOT

  Up to 2 years

• Number of participants who achieve RBC-TI over any consecutive 12-, 16-, and 24-week periods from Week 1 to Week 24, from Week 1 to Week 48 and from Week 1 through EOT

  Up to 2 years

Study Arms (2)

Cohort 1: erythropoiesis-stimulating agents (ESA) naïve

EXPERIMENTAL

Drug: Luspatercept

Cohort 2: ESA relapsed or refractory

EXPERIMENTAL

Drug: Luspatercept

Interventions

Luspatercept DRUG

Specified dose on specified days.

Also known as: BMS-986346, ACE-536, REBLOZYL

Cohort 1: erythropoiesis-stimulating agents (ESA) naïve; Cohort 2: ESA relapsed or refractory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (52)

Local Institution - 0051

Los Alamitos, California, 90720-3309, United States

Location

Local Institution - 0033

New Haven, Connecticut, 06510, United States

Location

Local Institution - 0055

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0056

Wellington, Florida, 33414, United States

Location

Local Institution - 0020

Kansas City, Kansas, 66160-8500, United States

Location

Local Institution - 0025

Paducah, Kentucky, 42003-7915, United States

Location

Local Institution - 0011

Detroit, Michigan, 48202, United States

Location

Local Institution - 0059

St Louis, Missouri, 63110, United States

Location

Local Institution - 0058

Morristown, New Jersey, 07960-6136, United States

Location

Local Institution - 0032

New York, New York, 10029, United States

Location

Local Institution - 0054

Eugene, Oregon, 97401-6043, United States

Location

Local Institution - 0036

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 0043

Amarillo, Texas, 79106-1781, United States

Location

Local Institution - 0022

Huntsville, Texas, 77340-4101, United States

Location

Local Institution - 0031

Wheeling, West Virginia, 26003, United States

Location

Local Institution - 0003

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 0016

Leuven, Vlaams Brabant, 3000, Belgium

Location

Local Institution - 0008

Roeselare, West-Vlaanderen, 8800, Belgium

Location

Local Institution - 0023

Prague, Praha, Hlavní Mesto, 128 20, Czechia

Location

Local Institution - 0004

Prague, Praha, Hlavní Mesto, 128 21, Czechia

Location

Local Institution - 0041

Nice, Alpes-Maritimes, 06202, France

Location

Local Institution - 0001

Poitiers, Vienne, 86021, France

Location

Local Institution - 0026

Angers, 49933, France

Location

Local Institution - 0007

Grenoble, 38 38043, France

Location

Local Institution - 0046

Paris, 75475, France

Location

Local Institution - 0053

Pierre-Bénite, 69495, France

Location

Local Institution - 0044

Tour Cedex01, 37044, France

Location

Local Institution - 0013

München, Bavaria, 81675, Germany

Location

Local Institution - 0040

Hanover, Lower Saxony, 30161, Germany

Location

Local Institution - 0009

Leipzig, Saxony, 04103, Germany

Location

Local Institution - 0021

Reggio Calabria, Calabria, 89124, Italy

Location

Local Institution - 0062

Napoli, Campania, 80131, Italy

Location

Local Institution - 0050

Rome, Lazio, 00133, Italy

Location

Local Institution - 0015

Pavia, Lombardy, 27100, Italy

Location

Local Institution - 0029

Rozzano (MI), Milano, 20089, Italy

Location

Local Institution - 0014

Novara, Piedmont, 28100, Italy

Location

Local Institution - 0045

Turin, Piedmont, 10128, Italy

Location

Local Institution - 0024

Florence, Tuscany, 50139, Italy

Location

Local Institution - 0049

Lódz, Lódzkie, 93-513, Poland

Location

Local Institution - 0010

Warsaw, Masovian Voivodeship, 02-172, Poland

Location

Local Institution - 0034

Katowice, 40-519, Poland

Location

Local Institution - 0035

Wałbrzych, 58-309, Poland

Location

Local Institution - 0047

San Juan, 00917, Puerto Rico

Location

Local Institution - 0017

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Local Institution - 0005

Barcelona, 08035, Spain

Location

Local Institution - 0052

Barcelona, 08916, Spain

Location

Local Institution - 0039

Granada, 18014, Spain

Location

Local Institution - 0038

Madrid, 28006, Spain

Location

Local Institution - 0027

Ourense, 32005, Spain

Location

Local Institution - 0028

Salamanca, 37007, Spain

Location

Local Institution - 0018

Valencia, 46010, Spain

Location

Local Institution - 0063

Valencia, 46026, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 5, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

ES (9); PR (1); BE (2); CZ (2); FR (7); DE (3); IT (8); US (16); PL (4)