Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Hematologic Malignancies
Status: Completed
Protocol number: ML18042
Sponsor: Productos Roche Q.F.S.A.
Company division: Pharmaceutical
Official Scientific Title: An Open-label study of the safety of NeoReocormon therapy in patients with anemia and low-grade non-Hodgkin's lymphoma,chronic lymphocytic leukemia or multiple myeloma
Brief summary: This study will evaluate the safety of subcutaneous NeoRecormon in patients with anemia and low-grade non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or multiple myeloma. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
10.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Safety: Adverse event rate and profile
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients >=18 years of age;
- low-grade non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or multiple myeloma;
- anemia.
Exclusion criteria:
- transfusion of red blood cells within 2 months of study;
- poorly-controlled hypertension;
- relevant acute or chronic bleeding (requiring treatment) within 3 months of study;
- anti-tumor therapy in the week before screening.
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: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Peru
