Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With Lymphoid Malignancies
Status: Completed
Protocol number: ML18185
Sponsor: Roche Polska Sp
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of NeoRecormon on quality of life in patients with anemia who have multiple myeloma, low-grade non-Hodgkin`s lymphoma, or chronic lymphocytic leukemia
Brief summary: This study will evaluate the efficacy, safety and effect on quality of life of subcutaneous NeoRecormon in patients with multiple myeloma, low grade non-Hodgkin's lymphoma or chronic lymphocytic leukaemia. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 94.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: Change from baseline in Quality of Life (FACT-An)
Key secondary outcomes: 1. Efficacy: Hemoglobin level response rate till week 16; transfusion requirements. Safety: Adverse event rate and profile; safety laboratory tests; iron parameters; and blood pressure
Inclusion criteria:
- adult patients >=18 years of age;
- multiple myeloma, low-grade non-Hodgkin's lymphoma, or chronic lymphocytic leukaemia;
- anemia;
- low erythropoietin levels;
- receiving anti-tumor therapy.
Exclusion criteria:
- poorly controlled hypertension;
- recombinant human erythropoietin therapy or any other erythropoiesis-stimulating drug in 2 months before study drug;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Poland
