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- Diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease
- < 5% blasts in bone marrow.
- Peripheral blood white blood cell (WBC) count < 13,000/µL.
- Anemia defined as:
- In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks, Hgb concentration ≤ 10.0 g/dL OR
- In low transfusion burden (LTB) participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
- In high transfusion burden (HTB) participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).
- Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
- Any active infection requiring parenteral antibiotic therapy within 28 days prior to Cycle 1 Day 1 or oral antibiotics within 14 days of Cycle 1 Day 1.
- Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- Vitamin B12 deficiency.
- Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- Treatment within 28 days prior to Cycle 1 Day 1 with:
a. Erythropoiesis stimulating agent (ESA) OR
b. Granulocyte colony-stimulating factor (G-CSF) OR
c. Granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
- Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
- Treatment with another investigational drug or device or approved therapy for investigational use < or = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
- Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
- Transferrin saturation < 15%.
- Ferritin < 50 µg/L.
- Folate < 4.5 nmol/L (< 2.0 ng/mL).
- Vitamin B12 < 148 pmol/L (< 200 pg/mL).
- Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
- Pregnant or lactating females.