Trial information
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Hematologic Malignancies.
Status: Terminated
Protocol number: ML18055
Sponsor: Roche Caracas
Company division: Pharmaceutical
Official Scientific Title: Open label multicenter study to investigate the safety of once weekly Neorecormon therapy in anemic patients with low grade non Hodgkin lymphoma, chronic lymphocytic leukemia or multiple myeloma
Brief summary: This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly NeoRecormon injections (30,000IU sc) in anemic patients with 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
30.
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. Hemoglobin levels at 16 weeks; quality of life; tolerability.
Key secondary outcomes: 1. Comparison of 3 different viral kinetic phases
Inclusion criteria:
- adult patients >=18 years of age;
- diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma;
- anemia.
Exclusion criteria:
- transfusion of red blood cells within 2 months of study drug;
- treatment-resistant hypertension;
- acute or chronic bleeding (requiring therapy) within 3 months of study drug.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/19/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Venezuela
