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

ClinicalTrials.gov ID: NCT06045689

Public ClinicalTrials.gov record NCT06045689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 16, 2026, 11:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT06045689
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Bristol-Myers Squibb; Industry
Enrollment: 106 participants

Conditions and interventions

Conditions

Myelodysplastic Syndromes

Interventions

Luspatercept Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 5, 2023 (Actual)
Primary completion: Oct 1, 2025 (Actual)
Completion: Sep 29, 2027 (Estimated)
Last update posted: Jun 15, 2026

2023 – 2027

United States locations

U.S. sites: 16
U.S. states: 14
U.S. cities: 16

Facility	City	State	ZIP	Site status
Local Institution - 0051	Los Alamitos	California	90720-3309	—
Local Institution - 0033	New Haven	Connecticut	06510	—
Local Institution - 0055	St. Petersburg	Florida	33705	—
Local Institution - 0056	Wellington	Florida	33414	—
Local Institution - 0020	Kansas City	Kansas	66160-8500	—
Local Institution - 0025	Paducah	Kentucky	42003-7915	—
Local Institution - 0011	Detroit	Michigan	48202	—
Local Institution - 0059	St Louis	Missouri	63110	—
Local Institution - 0058	Morristown	New Jersey	07960-6136	—
Local Institution - 0032	New York	New York	10029	—
Local Institution - 0054	Eugene	Oregon	97401-6043	—
Local Institution - 0036	Pittsburgh	Pennsylvania	15224	—
Local Institution - 0043	Amarillo	Texas	79106-1781	—
Local Institution - 0022	Huntsville	Texas	77340-4101	—
Local Institution - 0031	Wheeling	West Virginia	26003	—
Local Institution - 0003	Milwaukee	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06045689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 15, 2026 · Synced Oct 16, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06045689 live on ClinicalTrials.gov.

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