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OpenTrials
Completed

NCT Number: NCT02564094

A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Plovdiv, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults at least 18 years of age
  • Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
  • Anemia with low erythropoeitin (EPO) levels

Exclusion criteria

  • Poorly controlled hypertension
  • Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
  • Treatment with EPO within the last 6 weeks
  • Pregnant or breastfeeding females

Treatment and study plan

Epoetin beta

Drug

Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.

Other names: NeoRecormon

Primary outcomes

  1. Response rate according to hemoglobin level

    Time frame: At Week 4

  2. Transfusion requirement rate

    Time frame: From Weeks 5 to 12

  3. Predictive value of reticulocyte increase

    Time frame: At Week 2

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to approximately 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 30, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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