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Assessing Luspatercept for patients with low-risk Myelodysplastic Syndrome

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)

Phase 3 Interventional Bristol-Myers Squibb · NCT06045689

This study is testing if a new medication called Luspatercept can help people with low-risk Myelodysplastic Syndrome reduce their need for red blood cell transfusions.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations64 sites (Los Alamitos, California and 63 other locations)
Trial IDNCT06045689 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Luspatercept, a medication designed to treat anemia, in participants diagnosed with low-risk Myelodysplastic Syndromes (MDS) who require red blood cell transfusions. Participants will receive Luspatercept at the maximum approved dose to determine its effectiveness in reducing the need for transfusions. The study aims to enroll individuals with specific risk classifications according to the International Prognostic Scoring System. The outcomes will help establish the potential benefits of this treatment for managing MDS-related anemia.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with low-risk Myelodysplastic Syndrome who require regular red blood cell transfusions.

Not a fit: Patients with anemia due to deficiencies or those who have had prior stem cell transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the need for blood transfusions in patients with low-risk Myelodysplastic Syndrome.

How similar studies have performed: Previous studies have shown promising results with Luspatercept in treating anemia in similar patient populations, indicating a potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Los Alamitos, California and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myelodysplastic SyndromesLuspaterceptTransfusion dependentACE-536AnemiaBlood TransfusionRed Blood Cell TransfusionMyelodysplastic Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.