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