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Long-term Safety Study of Luspatercept for MDS, Beta-thalassemia, and Myelofibrosis

This study is looking at the long-term safety of luspatercept (ACE-536) in people who have already participated in other luspatercept clinical trials. Luspatercept is a treatment for conditions like Myelodysplastic Syndromes (MDS), Beta-thalassemia, and Myelofibrosis. The study aims to see how many side effects (Adverse Events) occur and if participants progress to higher-risk MDS or acute myeloid leukemia (AML) over approximately five years. You may be able to join if you are 18 or older and were previously treated with luspatercept or a placebo in a parent study, or are currently receiving luspatercept and your doctor believes you would benefit from continuing treatment. The study is open-label, meaning both you and your doctors will know you are receiving luspatercept.

Study design
This is a Phase 3b, open-label, single-arm study. It plans to enroll about 665 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for at least 42 days after treatment. They will also be followed for progression to high/very high risk MDS or AML for approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04064060

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Recruiting
PHASE3Ages 18+InterventionalTreatment
Celgene
~665 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Luspatercept

At a glance

Recruiting sites
27 of 143 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events (AEs)
Measured over From enrollment until at least 42 Day Safety Follow-up Phase
+4 more outcomes measured

Conditions

Myelodysplastic Syndromes (MDS)
Beta-thalassemia
Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis

Explore related trials

Beta ThalassemiaMyelodysplastic SyndromeMyelofibrosis

Where it's being run

143 sites across 57 states
Italy18
France11
Germany10
United Kingdom9
Spain8
Israel6
Turkey (Türkiye)6
Greece5

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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What this trial measures

  • Adverse Events (AEs)From enrollment until at least 42 Day Safety Follow-up Phase

    Type, frequency, severity of AEs, relationship of treatment emergent adverse events to luspatercept

  • Number of participants progressing to high/very high risk MDS or AML.Enrollment to Long-term post-treatment follow-up (Approximately, 5 years)

    Progression to high/very high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) (MDS and myelofibrosis \[MF\] only).

  • Percentage of participants progressing to high/very high risk MDS or AMLEnrollment to Long-term post-treatment follow-up (Approximately, 5 years)

    Progression to high/very high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) (MDS and myelofibrosis \[MF\] only)

  • Number of participants developing other malignancies/pre-malignanciesEnrollment to Long-term post-treatment follow-up (Approximately, 5 years)

    Development of other malignancies/pre-malignancies

  • Percentage of participants developing other malignancies/pre-malignanciesEnrollment to Long-term post-treatment follow-up (Approximately, 5 years)

    Development of other malignancies/pre-malignancies