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Closed (no longer recruiting)Last updated: 7 February 2024

COMMANDS: This phase III trial is comparing an experimental drug with a standard therapy for the treatment of Anaemia caused by low- to intermediate- risk Myelodysplastic SyndromeA Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

Clinical summary

Summary

This trial is treating patients with Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions. Participants in this trial will be randomised into one of two treating arms, to receive luspatercept (1.0mg/kg subcutaneously every 3 weeks) or epoetin alpha (450 IU/kg subcutaneously every week) for up to a minimum of 24 weeks.

Conditions

This trial is treating patients with Anaemia.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

COMMANDS

More information

Trial Identifiers

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Trial sponsor

Celgene Corporation

Scientific Title

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

Eligibility

Inclusion

  • 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

  • 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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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