Darbepoetin Alfa With or Without IV Iron

• Time to achieving target hemoglobin (Hgb 11 g/dL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Incidence and severity of adverse events including historical events of interest [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

2 different doses of darbepoetin alfa will be administered subcutaneous (SC) on a Q3W schedule with or without the administration of intravenous (IV) iron supplementation in the treatment of anemia in subjects with non myeloid malignancies receiving multicycle chemotherapy and have hemoglobin levels ≤10.0 g/dL.

• Anemia
• Non-Myeloid Malignancies

• Drug: darbepoetin alfa
  Darbepoetin alfa will be administered at a fixed dose of either 300mcg or 500 mcg Q3W based on the subject's treatment arm assignment.
• Drug: IV iron dextran
  400 mg at each dosing visit if assigned
  Other Name: IV iron

• Active Comparator: darbepoetin alfa 300mcg plus IV iron Q3W
  Interventions:

  • Drug: darbepoetin alfa
  • Drug: IV iron dextran
• Active Comparator: darbepoetin alfa 300mcg Q3W
  Intervention: Drug: darbepoetin alfa
• Active Comparator: darbepoetin alfa 500 mcg Q3W
  Intervention: Drug: darbepoetin alfa
• Active Comparator: darbepoetin alfa 500 mcg plus IV iron Q3W
  Interventions:

  • Drug: darbepoetin alfa
  • Drug: IV iron dextran

Inclusion Criteria:

• Subjects with active non myeloid malignancy(cies) including lymphocytic leukemias
• Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy
• Anemia due to chemotherapy (screening Hgb <or = 10.0 g/dL)
• at least 18 years of age at screening

Exclusion Criteria:

• Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)
• Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy
• Active bleeding
• Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)
• Active, unstable systemic or chronic infection
• Planned elective surgery during the study where significant blood loss is expected
• Unstable angina, or uncontrolled cardiac arrhythmia
• Uncontrolled hypertension (diastolic blood pressure > 100 mmHg)
• History of pure red cell aplasia (PRCA)
• History of deep venous thrombosis
• Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status
• Any RBC transfusion within 28 days before randomization and/or during screening
• Subjects currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy
• Subjects currently receiving or planned to receive myeloablative radiation therapy
• Subjects who have received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study
• Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)
• Subject has known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study
• Subject has known sensitivity to iron administration
• Subjects who are pregnant or breast feeding