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ELEMENT-MDS: Luspatercept for Myelodysplastic Syndromes and Anemia

This study, called ELEMENT-MDS, is looking at how well and how safely two medicines, Luspatercept and Epoetin Alfa, work for adults with a type of blood disorder called Myelodysplastic Syndromes (MDS). MDS causes your body to not make enough healthy blood cells, leading to anemia (low red blood cell count). You might be able to join if you have a specific type of MDS (very low, low, or intermediate-risk) and your anemia doesn't currently require blood transfusions. The researchers want to see if these medicines can help improve your red blood cell count and prevent you from needing transfusions. The study plans to enroll 402 participants, but its current status is unclear.

Study design
This study is an interventional trial comparing Luspatercept to Epoetin Alfa. It plans to enroll 402 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track participants for up to 96 weeks to see if they start needing blood transfusions, and for up to 48 weeks to measure improvements in their hemoglobin levels.

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

NCT05949684

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~402 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:LuspaterceptEpoetin Alfa

At a glance

Recruiting sites
0 of 144 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period
Measured over Up to Week 96
+1 more outcome measured

Conditions

Myelodysplastic Syndromes

Explore related trials

Myelodysplastic SyndromeEPO Gene

Where it's being run

144 sites across 93 states
Florida8
California7
Germany6
Spain5
Santiago Metropolitan4
Italy4
Argentina3
New South Wales3

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and:.
Participant is not transfusion dependent (NTD) based on IWG2018 criteria.
Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
Participant has symptoms of anemia:.
Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.

Exclusion

Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
Participant with known history of diagnosis of AML.
Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.

What this trial measures

  • Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment periodUp to Week 96

    TD is defined as ≥ 3 red blood cells (RBC) units/16 weeks assessed by International Working Group (IWG) 2018.

  • Number of participants with an increase from baseline in mean Hb values of ≥ 1.5 grams/deciliter (g/dL) in any continuous 16-week interval within the 48 week Treatment Period in the absence of transfusionUp to Week 48