A randomized, open label, multicentre trial to define the most effective haemoglobin concentration to start erythropoietin beta (neoRecormon) therapy in anaemic subjects with lymphoproliferative malignancy receiving chemotherapy *REPOS Study*
Phase 3
Completed
- Conditions
- anemiamalignancy10018849
- Registration Number
- NL-OMON34234
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Patients with lymphoproliferative malignancy i.e. multipel myeloma, chronic lymphocytic leukemia, non hodgkins lymphoma and hodgkins lymphoma who will be treated with chemotherapy which may induce anaemia
Exclusion Criteria
transfusions or red bloodcells during the 2 weeks immediately prior to randomisation or rHuEPO within 12 weeks before inclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to treatment success, defined as increase in Hb * 1,2 mmol/l or a Hb<br /><br>concentration of * 7,4 mmol/l (without red blood cell transfusion)</p><br>
- Secondary Outcome Measures
Name Time Method <p> Incidence of Adverse Events during the treatment period<br /><br>Changes and abnormalities in laboratory safety parameters<br /><br>% response at week 12 and 16 (defined as treatment success at 12 weeks and no<br /><br>subsequent failure i.e. haemoglobin decrease below 7.2 mmol/l)<br /><br>Rate of increase in haemoglobin<br /><br>Number of RBC units transfused<br /><br>QoL (FACT- An and VAS)</p><br>