Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 243
- 主要终点
- Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Darbepoetin alfa 300 μg plus IV Iron
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).
干预措施: darbepoetin alfa (Drug)
Darbepoetin alfa 300 μg plus IV Iron
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).
干预措施: IV iron dextran (Drug)
Darbepoetin alfa 300 μg
Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
干预措施: darbepoetin alfa (Drug)
Darbepoetin alfa 500 μg
Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
干预措施: darbepoetin alfa (Drug)
Darbepoetin alfa 500 μg plus IV Iron
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).
干预措施: darbepoetin alfa (Drug)
Darbepoetin alfa 500 μg plus IV Iron
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).
干预措施: IV iron dextran (Drug)
结局指标
主要结局
Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose
时间窗: From Week 1 to Week 16
Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage
时间窗: From Week 1 to Week 16
Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
次要结局
- Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose(From Week 1 to Week 16)
- Time to Achieve the Target Hemoglobin Level, by IV Iron Usage(From Week 1 to Week 16)
- Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage(Baseline and Week 16)
- Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose(Baseline and Week 16)
- Change From Baseline in Hemoglobin Concentration, by IV Iron Usage(Baseline and Week 16)
- Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose(From Week 1 to Week 16)
- Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage(From Week 1 to Week 16)
- Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study(From Week 5 to Week 16)
- Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose(From Week 1 to Week 16)
- Number of Participants With a Hematopoietic Response, by IV Iron Usage(From Week 1 to Week 16)
- Time to Hematopoietic Response, by Darbepoetin Alfa Dose(From Week 1 to Week 16)
- Time to Hematopoietic Response, by IV Iron Usage(From Week 1 to Week 16)
- Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose(Baseline and Week 16)