Blood and Lymph Conditions

All Conditions

Anemia

Hematologic Diseases

Micronutrients

All Drugs and Chemicals

Anticoagulants

Blood Substitutes

Hematinics

Iron

Dextrans

Iron-Dextran Complex

Darbepoetin alfa

Plasma Substitutes

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).

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

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

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).

Darbepoetin alfa administered by subcutaneous injection.

darbepoetin alfa

Administered by intravenous (IV) injection.

IV iron dextran

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.

Darbepoetin Alfa With or Without Intravenous (IV) Iron

Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

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.

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.

Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).

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.

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.

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.

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.

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.

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.

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.

Darbepoetin Alfa 300 µg (Without IV Iron)

Darbepoetin Alfa 300 µg Plus Iron

Darbepoetin Alfa 500 µg (Without Iron)

Darbepoetin Alfa 500 µg Plus Iron

Darbepoetin Alfa 300 μg Plus Iron

Darbepoetin Alfa 300 μg

Darbepoetin Alfa 500 μg

Darbepoetin Alfa 500 μg Plus Iron

Total

Age, Continuous

Sex: Female, Male

Black or African American

Hispanic or Latino

Asian

Other

White or Caucasian

Race/Ethnicity, Customized

Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale score, ranging from 0 to 52, where 0 = worst outcome and higher scores represent less fatigue.

FACT-Fatigue Score

Hemoglobin

Study Director

Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Combined Darbepoetin Alfa 300 μg

Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Combined Darbepoetin Alfa 500 μg

Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.

Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose

Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Combined Without Iron Groups

Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Combined With Iron Groups

Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage

Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose

Time to Achieve the Target Hemoglobin Level, by IV Iron Usage

Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.

Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose

Change From Baseline in Hemoglobin Concentration, by IV Iron Usage

Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.

Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose

Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage

Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5.

Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study

Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.

Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose

Number of Participants With a Hematopoietic Response, by IV Iron Usage

Combined Darbepoetin Alfa 300

Time to Hematopoietic Response, by Darbepoetin Alfa Dose

Time to Hematopoietic Response, by IV Iron Usage

Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.

Spots Global Cancer Trial Database for Darbepoetin Alfa With or Without Intravenous (IV) Iron

Trial Identification

Conditions

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Study Description

Keywords

Eligibility

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Contact Details

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