Clinical trial NCT01626547: Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology
Official title: Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Symptomatic Anaemia
Solid Tumours
Malignant Lymphomas
Multiple Myeloma
Keywords: symptomatic anameia
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chemotherapy-induced symptomatic anaemia. Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.

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.

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.

Primary outcomes:
measure: Change and corrected Hemoglobin levels
timeFrame: 6 months
Secondary outcomes:
measure: Observation of blood value development
timeFrame: 6 months
measure: Evaluation of the profiles of treated patients
timeFrame: 6 months
measure: Evaluation of prescriber's therapy plan
timeFrame: 6 months
measure: Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics
timeFrame: 6 months
measure: Observation of the tolerability profile of Epoetin Zeta
timeFrame: 6 months
Other outcomes:
Locations:
city: Alzey
country: Germany
city: Bad Säckigen
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Bonn
country: Germany
city: Borken
country: Germany
city: Brandenburg
country: Germany
city: Chemnitz
country: Germany
city: Cottbus
country: Germany
city: Essen
country: Germany
city: Frankenthal
country: Germany
city: Garbsen
country: Germany
city: Halberstadt
country: Germany
city: Hannover
country: Germany
city: Herne
country: Germany
city: Holzkirchen
country: Germany
city: Krefeld
country: Germany
city: München
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Neuss
country: Germany
city: Nürnberg
country: Germany
city: Oberhausen
country: Germany
city: Oberhausen
country: Germany
city: Olpe
country: Germany
city: Oranienburg
country: Germany
city: Paderborn
country: Germany
city: Parchim
country: Germany
city: Plauen
country: Germany
city: Remscheid
country: Germany
city: Rodgau
country: Germany
city: Rötha
country: Germany
city: Schönebeck
country: Germany
city: Soest
country: Germany
city: Stralsund
country: Germany
city: Stuttgart
country: Germany
city: Velbert
country: Germany
Study officials:
References: