Clinical trial NCT00401544: Darbepoetin Alfa With or Without Intravenous (IV) Iron
Official title: Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Non-Myeloid Malignancies
Keywords: anemia
chemotherapy induced anemia
darbepoetin alfa
cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose
timeFrame: From Week 1 to Week 16
measure: Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage
timeFrame: From Week 1 to Week 16
Secondary outcomes:
measure: Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose
timeFrame: From Week 1 to Week 16
measure: Time to Achieve the Target Hemoglobin Level, by IV Iron Usage
timeFrame: From Week 1 to Week 16
measure: Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hemoglobin Concentration, by IV Iron Usage
timeFrame: Baseline and Week 16
measure: Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose
timeFrame: From Week 1 to Week 16
measure: Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage
timeFrame: From Week 1 to Week 16
measure: Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study
timeFrame: From Week 5 to Week 16
measure: Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose
timeFrame: From Week 1 to Week 16
measure: Number of Participants With a Hematopoietic Response, by IV Iron Usage
timeFrame: From Week 1 to Week 16
measure: Time to Hematopoietic Response, by Darbepoetin Alfa Dose
timeFrame: From Week 1 to Week 16
measure: Time to Hematopoietic Response, by IV Iron Usage
timeFrame: From Week 1 to Week 16
measure: Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose
timeFrame: Baseline and Week 16
measure: Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Auerbach M, Silberstein PT, Webb RT, Averyanova S, Ciuleanu TE, Shao J, Bridges K. Darbepoetin alfa 300 or 500 mug once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. 2010 Sep;85(9):655-63. doi: 10.1002/ajh.21779.