Drug combo aims to break anemia cycle in MDS patients

NCT ID NCT04539236

Terminated Disease control Sponsor: Mikkael Sekeres, MD Source: ClinicalTrials.gov ↗

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether combining two drugs, luspatercept and lenalidomide, can improve anemia in people with lower-risk myelodysplastic syndrome (MDS) who lack a specific chromosome change. Participants take lenalidomide daily by mouth and receive luspatercept as a shot under the skin every three weeks. The goal is to find the best dose and see if the combination reduces the need for red blood cell transfusions.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: a combination of the drugs luspatercept and lenalidomide
What this could lead to: If successful, this combination could offer a new treatment option for anemia in lower-risk MDS patients who do not have a specific chromosome abnormality.
What could go wrong: This is an early-phase trial with a small number of participants, so the results may not apply to all patients. The combination may cause side effects or not improve anemia significantly.

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MYELODYSPLASTIC SYNDROMES

Contacts and locations

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Locations

Cleveland Clinic

Cleveland, Ohio, 44195, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Johns Hopkins University

Baltimore, Maryland, 21287, United States
University of Miami

Miami, Florida, 33136, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

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