Anemia in cancer patients
Conditions
Interventions
Product Name: NeoRecormon
Pharmaceutical Form: Solution for injection
Sponsors
Haga Teaching Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? patients with lymphoproliferative malignancy i.e. Multiple Myeloma (MM), Chronic Lymphocytic Leukaemia (CLL), Non Hodgkin Lymphoma (NHL) and Hodgkin’s Lymphoma (HL). ? chemotherapy induced anaemia with a Hb concentration within the range 6.2–7.2 mmol/l within 2 weeks prior to randomisation. ? at least 12 additional; weeks of cytotoxic chemotherapy planned, regardless of schedule. ? age >18 years. ? life expectancy > 6 months. ? if systemic anticancer therapy is to be given, it should be scheduled for at least 12 weeks from the time of first study treatment. Patients who are currently receiving systemic anticancer therapy will be eligible. ? written informed consent before any study-specific procedure, including screening procedures, was done. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Transfusion of red blood cells during the 2 weeks immediately prior to randomization. ? rHuEPO treatment within 12 weeks before inclusion. ? Known (documented) primary haematological disorder that could cause anaemia, other than a lymphoproliferative malignancy (e.g. sickle cell anaemia). ? Clinically significant active flammatory disease, as determined by principal investigator (e.g. rheumatoid arthritis, Chron’s disease). ? Performance status = 3 according to the ECOG scale: ? iron deficiency (transferrine saturation 5x ULN) ? history of significant neurological or psychiatric disorders including psychotic disorders or dementia; ? documented unstable or uncontrolled disease or condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure (New York Heart Association Class > II, uncontrolled hypertension (diastolic heart pressure > 100 mmHg) and or cardiac arrhythmia) ; ? known history of allergy to any of the study medications or their excipients. ? females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment. Male and female patients with reproductive potential must use an approved contraceptive method (e.g. intrauterine device (IUD), birth control pills or barrier device) during the study and for 3 months after the study. ? any unregistered drug in the 30 days preceding the first dose of the study medication or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare haemoglobuline responses (defined as Hb concentrations >= 1.2 mmol/l), numbers of transfused RBC units, the effect on quality of life ( FACT-Fatique scale and VAS) from baseline to end of treatment, and the overall safety profile in patients;Main Objective: To compare the efficacy of erythropoietin beta administered weekly using an early start approach ( Hb <= 7.2 mmol/l) with standard starting approach ( Hb <= 6,2 mmol/l) in subjects with lymphoproliferatieve malignancy, receiving chemotherapy during an 16-week treatment phase, as measured by the proportion of subjects requiring a RBC transfusion overall and between baseline and week 5.;Primary end point(s): 1. primary endpoint for the study is defined as the Time to treatment success will be presented as a Kaplan Meier curve for each subgroup. A two-sided log rank test will be performed to test for differences between the two treatment groups. 2. Absolute % of patients requiring transfusion will be compared for each treatment arm using a two sided ?2 test for both the treatment period and from commencement of the observation phase. 3. Absolute % response at week 12 and 16 compared for each treatment arm using a two sided ?2 test. 4. Proportion of patients with Haemoglobin controlled within target range at 12 and 16 weeks will be compared for each subgroup using a two sided ?2 test. | — |
Countries
Netherlands
Outcome results
None listed