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 (COMMANDS)

Celgene

Status and phase: Active, not recruiting; Phase 3

Conditions: Myelodysplastic Syndromes

Treatments: Drug: Luspatercept; Drug: Epoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT03682536

ACE-536-MDS-002

2022-501485-22 (Other Identifier)

U1111-1218-1810 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 363 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
• Endogenous serum erythropoietin (sEPO) level of < 500 U/L
• Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

Exclusion criteria

• Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
• Known history of diagnosis of Acute myeloid leukemia (AML)
• Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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363 participants in 2 patient groups

Luspatercept

Experimental group

Treatment:

Drug: Luspatercept

Epoetin alfa

Active Comparator group

Treatment:

Drug: Epoetin alfa