Darbepoetin Alfa With or Without Intravenous (IV) Iron

Amgen

Status and phase: Completed; Phase 2

Conditions: Anemia; Non-Myeloid Malignancies

Treatments: Drug: darbepoetin alfa; Drug: IV iron dextran

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401544

20060103

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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243 participants in 4 patient groups

Darbepoetin alfa 300 μg plus IV Iron

Experimental group

Description:

Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Treatment:

Drug: IV iron dextran

Drug: darbepoetin alfa

Darbepoetin alfa 300 μg

Experimental group

Description:

Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Treatment:

Drug: darbepoetin alfa

Darbepoetin alfa 500 μg

Experimental group

Description:

Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Treatment:

Drug: darbepoetin alfa

Darbepoetin alfa 500 μg plus IV Iron

Active Comparator group

Description:

Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Treatment:

Drug: IV iron dextran

Drug: darbepoetin alfa