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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
243
Darbepoetin alfa administered by subcutaneous injection.
Administered by intravenous (IV) injection.
Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose
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.
Time frame: From Week 1 to Week 16
Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage
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.
Time frame: From Week 1 to Week 16
Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose
The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Time to Achieve the Target Hemoglobin Level, by IV Iron Usage
The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose
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Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
Time frame: Baseline and Week 16
Change From Baseline in Hemoglobin Concentration, by IV Iron Usage
Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
Time frame: Baseline and Week 16
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose
The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
Time frame: 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
The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
Time frame: From Week 1 to Week 16
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study
Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
Time frame: From Week 5 to Week 16
Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose
Number of participants with a hematopoietic response, defined as \> 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.
Time frame: From Week 1 to Week 16
Number of Participants With a Hematopoietic Response, by IV Iron Usage
Number of participants with a hematopoietic response, defined as \> 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.
Time frame: From Week 1 to Week 16
Time to Hematopoietic Response, by Darbepoetin Alfa Dose
The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Time to Hematopoietic Response, by IV Iron Usage
The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
Time frame: From Week 1 to Week 16
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose
Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
Time frame: Baseline and Week 16
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage
Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
Time frame: Baseline and Week 16