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

June 12, 2026 updated by: Bristol-Myers Squibb

A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain the NCT# and Site#

Study Contact Backup

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Local Institution - 0016
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Local Institution - 0008
  • Czechia
    • Praha, Hlavní Mesto
      • Prague, Praha, Hlavní Mesto, Czechia, 128 20
        • Local Institution - 0023
      • Prague, Praha, Hlavní Mesto, Czechia, 128 21
        • Local Institution - 0004
  • France
      • Angers, France, 49933
        • Local Institution - 0026
      • Grenoble, France, 38 38043
        • Local Institution - 0007
      • Paris, France, 75475
        • Local Institution - 0046
      • Pierre-Bénite, France, 69495
        • Local Institution - 0053
      • Tour Cedex01, France, 37044
        • Local Institution - 0044
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Local Institution - 0041
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Local Institution - 0001
  • Germany
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Local Institution - 0013
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30161
        • Local Institution - 0040
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Local Institution - 0009
  • Italy
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89124
        • Local Institution - 0021
    • Campania
      • Naples, Campania, Italy, 80131
        • Local Institution - 0062
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Local Institution - 0050
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Local Institution - 0015
    • Milano
      • Rozzano (MI), Milano, Italy, 20089
        • Local Institution - 0029
    • Piedmont
      • Novara, Piedmont, Italy, 28100
        • Local Institution - 0014
      • Turin, Piedmont, Italy, 10128
        • Local Institution - 0045
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Local Institution - 0024
  • Poland
      • Katowice, Poland, 40-519
        • Local Institution - 0034
      • Wałbrzych, Poland, 58-309
        • Local Institution - 0035
    • Lódzkie
      • Lódz, Lódzkie, Poland, 93-513
        • Local Institution - 0049
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • Local Institution - 0010
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Local Institution - 0047
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0005
      • Barcelona, Spain, 08916
        • Local Institution - 0052
      • Granada, Spain, 18014
        • Local Institution - 0039
      • Madrid, Spain, 28006
        • Local Institution - 0038
      • Ourense, Spain, 32005
        • Local Institution - 0027
      • Salamanca, Spain, 37007
        • Local Institution - 0028
      • Valencia, Spain, 46010
        • Local Institution - 0018
      • Valencia, Spain, 46026
        • Local Institution - 0063
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Local Institution - 0017
  • United States
    • California
      • Los Alamitos, California, United States, 90720-3309
        • Local Institution - 0051
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Local Institution - 0033
    • Florida
      • St. Petersburg, Florida, United States, 33705
        • Local Institution - 0055
      • Wellington, Florida, United States, 33414
        • Local Institution - 0056
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • Local Institution - 0020
    • Kentucky
      • Paducah, Kentucky, United States, 42003-7915
        • Local Institution - 0025
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Local Institution - 0011
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0059
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6136
        • Local Institution - 0058
    • New York
      • New York, New York, United States, 10029
        • Local Institution - 0032
    • Oregon
      • Eugene, Oregon, United States, 97401-6043
        • Local Institution - 0054
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution - 0036
    • Texas
      • Amarillo, Texas, United States, 79106-1781
        • Local Institution - 0043
      • Huntsville, Texas, United States, 77340-4101
        • Local Institution - 0022
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Local Institution - 0031
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Local Institution - 0003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: erythropoiesis-stimulating agents (ESA) naïve
Drug: Luspatercept
Specified dose on specified days.
Other Names:
  • ACE-536
  • BMS-986346
  • REBLOZYL
Experimental: Cohort 2: ESA relapsed or refractory
Drug: Luspatercept
Specified dose on specified days.
Other Names:
  • ACE-536
  • BMS-986346
  • REBLOZYL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: Up to week 24
Up to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 2 years
Up to 2 years
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
Time Frame: Up 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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
Up to 2 years
Number of participants with an increase from baseline in mean hemoglobin (Hb) values of ≥ 1.0 g/dL over any consecutive 8-week period in absence of RBC transfusions from Week 1 to Week 48 and from Week 1 through EOT
Time Frame: Up to 2 years
Up to 2 years
Number of participants with an increase from baseline in Hb values of ≥ 1.0 g/dL over any consecutive 16-week period in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Time Frame: Up to 2 years
Up to 2 years
Number of participants with an increase from baseline in Hb values of ≥ 1.5 g/dL over any consecutive 8-, and 16-week periods in absence of RBC transfusions from Week 1 to Week 24, from Week 1 to Week 48, and from Week 1 through EOT
Time Frame: Up to 2 years
Up to 2 years
Number of participants who achieve Hematological Improvement Erythroid (mHI-E) per International Working Group-2018 (IWG-2018) over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Time Frame: Up to 2 years
Up to 2 years
Number of participants who achieve Hematological Improvement - Neutrophils (HI-N) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Time Frame: Up to 2 years
Up to 2 years
Number of participants who achieve Hematological Improvement - Platelets (HI-P) per IWG-2018 over any consecutive 8-week period from Week 1 to Week 24, from Week 1 to Week 48, and Week 1 through EOT
Time Frame: Up to 2 years
Up to 2 years
Number of participants with change in serum ferritin (SF) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Time Frame: Up to week 48
Up to week 48
Number of participants with change in mean daily dose of iron chelation therapy (ICT) over a 16-week period from Week 9 to Week 24 and from Week 33 to Week 48
Time Frame: Up to week 48
Up to week 48
Number of participants with acute myeloid leukemia (AML) progression
Time Frame: Up to 4 years
Up to 4 years
Time to AML progression
Time Frame: Up to 4 years
Up to 4 years
Time from treatment start date to death due to any cause
Time Frame: Up to 4 years
Up to 4 years
Number of participants with a change in subscale scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from Week 1 to Week 48 and from baseline through EOT
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA056-1060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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