Darbepoetin Alfa With or Without Intravenous (IV) Iron
Condition: Anemia; Non-Myeloid Malignancies
MeSH terms: Neoplasms; Anemia
Intervention: darbepoetin alfa; IV iron dextran
Intervention description: Darbepoetin alfa administered by subcutaneous injection.; Administered by intravenous (IV) injection.
Intervention MeSH terms: Dextrans; Darbepoetin alfa; Iron-Dextran Complex
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; chemotherapy induced anemia; darbepoetin alfa; cancer

Summary:

      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.
    

Eligibility criteria:

        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