AIM 3: Anemia and Iron Management With Every 3 Week Dosing in Anemic Subjects With Nonmyeloid Malignancies

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: August 24, 2005
Last updated: May 21, 2013
Last verified: May 2013

The study is designed to assess if the addition of intravenous (IV) iron to 500 mcg every 3 week (Q3W) darbepoetin alfa treatment enhances response as compared to the standard practice (oral iron or no iron administration).

Condition Intervention Phase
Drug: darbepoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open-Label Study of Darbepoetin Alfa Administered Every Three Weeks With or Without Parenteral Iron in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of subjects achieving a hematopoietic response (hemoglobin [hgb] greater than or equal to 12 g/dL or rise in hgb of greater than 2 g/dL) during the treatment period

Secondary Outcome Measures:
  • Time to hematopoietic response in days
  • The proportion of subjects with at least one red blood cell (RBC) transfusion from week 5 (day 29) to end of treatment period (EOTP)
  • Change in hemoglobin from baseline to EOTP
  • The proportion of subjects achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP
  • The average hgb after achieving a hgb level greater than or equal to 11.0 g/dL
  • Patient reported outcomes: Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale score from baseline to EOTP
  • Change in FACT-G Physical Well-being subscale from baseline to EOTP
  • Change in FACT-G total score from baseline to EOTP
  • Change in EuroQoL (EQ-5D) thermometer and ED-5D scores from baseline to EOTP

Study Start Date: November 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria: - Subjects with non-myeloid malignancy (chronic myeloid leukemia [CML], acute leukemia [acute myelogenous leukemia (AML) and acute lymphocytic leukemia (ALL)], hairy cell leukemia, Burkitt's lymphoma and lymphoblastic lymphoma are specifically excluded) - Planned to receive at least 8 weeks of cyclic cytotoxic chemotherapy regardless of schedule (chemotherapy may already be ongoing at time of screening) - Hemoglobin concentration less than 11 g/dL within 24 hours before randomization - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Known (documented in medical records) history of seizure disorder (subjects with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and have not been taking anti-seizure medication for the previous 5 years) - Known (documented in medical records) history of thromboembolism - Known primary hematologic disorder which could cause anemia other than a non-myeloid malignancy (e.g., sickle cell anemia, thalassemia) - Radiotherapy within 4 weeks before randomization in which the radiation is administered to greater than 25% of the marrow - Unstable or uncontrolled disease/condition, related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia) - Chronic inflammatory disease that is not stable (e.g., rheumatoid arthritis, Crohn's disease, peptic ulcer, ulcerative disease, etc) - Inadequate renal and/or liver function - Received any red blood cell transfusion within 14 days before randomization or any planned red blood cell transfusion between randomization and study day 1 - Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1 - Known sensitivity to iron administration - Subject of reproductive potential is evidently pregnant (e.g., positive serum HCG test) or is breast feeding - Subject of reproductive potential who is not using adequate contraceptive precautions - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

  Contacts and Locations
Please refer to this study by its identifier: NCT00135317

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT00135317     History of Changes
Other Study ID Numbers: 20040156
Study First Received: August 24, 2005
Last Updated: May 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Amgen:
darbepoetin alfa
Non-myeloid malignancy

Additional relevant MeSH terms:
Darbepoetin alfa
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 23, 2014