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Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2

Phase 4
18 Years
Not Enrolling
Anemia, Neoplasms

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Trial Information

Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2

Anemia has been identified as a common complication and a widespread problem in the cancer
population. Anemia is a condition in which a patient has below normal levels of hemoglobin,
the substance in red blood cells that carries oxygen to all parts of the body. People with
severe anemia may experience fatigue and shortness of breath with activity. Therefore, this
condition can have a negative influence on a person's quality of life. Epoetin alfa, used to
treat anemia in cancer patients, is a genetically engineered protein that stimulates red
blood cell production. This study investigates treatment of anemia using epoetin alfa during
chemotherapy in adult patients with cancer. The study is intended to collect information on
normal medical practice and routine anemia management performed at the participating
centers. This is an observational, non-randomized, prospective, comparative, parallel-group
survey performed in The Netherlands. Patients with various severities of disease may enter
the survey as soon as their epoetin alfa treatment starts and will be followed until the end
of their epoetin alfa treatment. Patient data are collected in Case Report Forms (CRFs)
until 4 weeks after the end of treatment with epoetin alfa. At the end of treatment
completed CRFs will be collected. The assessment of effectiveness/response will be based on
the following: cancer type and status, chemotherapy and other anti-cancer treatment,
hemoglobin levels, use of blood transfusions, and serum iron levels and iron
supplementation. Safety evaluations include the incidence of serious and non-serious adverse
events. Because the study is observational, dosage, administration and duration of treatment
is at discretion of treating physician.

Inclusion Criteria:

- Patients with a diagnosis of solid tumors, multiple myeloma (Kahlers' disease),
non-Hodgkin lymphoma or Hodgkins' disease

- Patients must already be receiving chemotherapy or start their first cycle within a
week of enrollment

- Patients must receive epoetin alfa treatment (expected treatment duration is at least
4 weeks)

Exclusion Criteria:

- Patients who cannot read the Dutch language and/or do not understand the Dutch
Informed Consent Form and patients participating in either of our observational

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

The assessment of effectiveness based on: epoetin alfa treatment schedule (dose and timing), hemoglobin effect, response to treatment (independent of blood transfusion), mean time to response, # of blood transfusions given, and iron supplementation

Outcome Time Frame:

4 weeks, 8 weeks and end of treatment

Safety Issue:


Principal Investigator

Janssen-Cilag B.V. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag B.V.


Netherlands: Independent Ethics Committee

Study ID:




Start Date:

October 2005

Completion Date:

November 2009

Related Keywords:

  • Anemia
  • Neoplasms
  • Anemia
  • Neoplasms
  • Antineoplastic agents
  • Chemotherapy
  • Efficacy
  • Epoetin alfa
  • Anemia
  • Neoplasms