Clinical Trial

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

Study acronym: COMMANDS

Active, Not Recruiting Phase 3

Summary

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Protocol Amendment History 82 amendments

This ClinicalTrials.gov record has been amended 82 times since 2018-09-20; most recent amendment 2024-11-04.

Status change: Recruiting → Active, Not Recruiting 2022-09-14

Status change: Not Yet Recruiting → Recruiting 2018-10-30

Trial Details

NCT Number	NCT03682536
Lead Sponsor	Celgene Collaborators: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions	Myelodysplastic Syndromes
Enrollment	363 participants
Start Date	2019-01-02
Primary Completion	2023-03-31 (estimated)
Study Completion	2027-09-28 (estimated)
Updated on ClinicalTrials.gov	2024-11-20