Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

NCT ID: NCT01626547

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 291 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-07-31

Brief Summary

The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.

Detailed Description

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study in adult patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with Retacrit® to correct haemoglobin levels.

Conditions

Chemotherapy-induced Symptomatic Anaemia; Solid Tumours; Malignant Lymphomas; Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients age ≥18 years .
• Patients present with chemotherapy-induced symptomatic anaemia.
• Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.

• The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
• Patients eligible for epoetin alfa biosimilar treatment.

Exclusion Criteria

• Patients are not receiving chemotherapy.
• Patients already included in an epoetin zeta study.
• Patients presenting with the contraindications to epoetin zeta.
• Patients presenting with the hypersensitivity to the active substance or any of the excipients.
• The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA).
• Patients with uncontrolled hypertension.
• Patients who cannot receive adequate prophylaxis by antithrombotic agents.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alzey, , Germany

Bad Säckigen, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bonn, , Germany

Bonn, , Germany

Borken, , Germany

Brandenburg, , Germany

Chemnitz, , Germany

Cottbus, , Germany

Essen, , Germany

Frankenthal, , Germany

Garbsen, , Germany

Halberstadt, , Germany

Hanover, , Germany

Herne, , Germany

Holzkirchen, , Germany

Krefeld, , Germany

München, , Germany

München, , Germany

Münster, , Germany

Neuss, , Germany

Nuremberg, , Germany

Oberhausen, , Germany

Oberhausen, , Germany

Olpe, , Germany

Oranienburg, , Germany

Paderborn, , Germany

Parchim, , Germany

Plauen, , Germany

Remscheid, , Germany

Rodgau, , Germany

Rötha, , Germany

Schönebeck, , Germany

Soest, , Germany

Stralsund, , Germany

Stuttgart, , Germany

Velbert, , Germany

Countries

Germany

Other Identifiers

ORHEO

Identifier Type: -

Identifier Source: org_study_id