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

Multiple Myeloma Clinical Trial

Official title:

Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626547
• Other study ID #: ORHEO
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: March 16, 2017
• Start date: December 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2015
• Source: Hospira, now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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™.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Chemotherapy-induced Symptomatic Anaemia
• Lymphoma
• Malignant Lymphomas
• Multiple Myeloma
• Solid Tumours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change and corrected Hemoglobin levels	Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.	6 months
Secondary	Observation of blood value development	Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation	6 months
Secondary	Evaluation of the profiles of treated patients		6 months
Secondary	Evaluation of prescriber's therapy plan		6 months
Secondary	Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics		6 months
Secondary	Observation of the tolerability profile of Epoetin Zeta		6 months