Darbepoetin Alfa With or Without Intravenous (IV) Iron

Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.

Inclusion Criteria:

• 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:

• 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 red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening
• Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy
• Currently receiving or planned to receive myeloablative radiation therapy
• 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)
• Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study
• Known sensitivity to iron administration
• Pregnant or breast feeding