D61.10
Conditions
Sponsors
Hexal AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis of solid tumour, malignant lymphoma or multiple myeloma; 2. Tumour therapy with chemotherapy alone or in combination with other therapies; 3.Therapy with Epoetin alfa HEXAL for symptomatic anaemia and a reduction of transfusions is planned for three to six chemotherapy cycles; 4. Written informed consent of patients available covering pro- and retrospective pseudonymised documentation, transmission and analysis of data as well as inspection of data during monitoring.
Exclusion criteria
Exclusion criteria: 1. Patient is treated within another study; 2. Tumour therapy consists of radiation alone; 3. Patient suffers from acute leucaemia or chronic myeloproliferative syndrome; 4. Patient suffers from non-treated haemolytic anaemia or from iron, vitamin B12 or folic acid deficiency anaemia not related to the tumour; 5. Patient has participated in the same study earlier; 6. Contraindications to Epoetin alfa HEXAL according to the current summary of product characteristics. 7. Female patients: Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Management of anaemia with Epoetin alfa HEXAL: baseline haemoglobin (Hb), changes of Hb, start dose and dose adjustments, achievement of target Hb, duration and temporary discontinuations of therapy, lab parameters of iron metabolism, iron Supplementation; motives for the use of Epoetin; consideration of guidelines. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile of Epoetin alfa HEXAL: Blood pressure, haematological and clinical chemistry lab, arterial and/or venous thromboembolic or other cardiovascular events, AEs (adverse events) [per cycle, AEs continuously]. Clinical effectiveness: Haematological and clinical chemistry lab, number of red blood cell transfusions [per cycle]; Epoetin self-application: Adequate patient information, experience, Performance [last cycle]; Change of quality of life: LASA scale (Linear Analogue Scale Assessment) [first and last cycle]; Course of anthracycline induced cardiomyopathy under therapy with Epoetin alfa: LVEF (left ventricular ejection fraction), cardiac troponin, natriuretic peptides [start of chemotherapy line, one further documentation over the study period, as far as routinely determined]. | — |
Countries
Germany
Contacts
Public ContactDietmar Bulenda
Hexal AG
Outcome results
None listed