Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With Solid Tumors or Hematologic Malignancies
Status: Completed
Protocol number: ML18043
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: An open-label study of NeoRecormon on hemoglobin level/correction in patients with hematologic malignancies or solid tumors.
Brief summary: This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous NeoRecormon in patients with hematologic malignancies or solid tumors. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
60.
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: Response rate until weeks 8 and 16; transfusion requirements; average weekly dose needed at response Week 16; changes in hemoglobin and hematocrit values versus baseline.
Key secondary outcomes: 1. Safety: Adverse events; Pharmacoeconomics: treatment-related and AE-related spending/savings.
Inclusion criteria:
- adult patients >=18 years of age;
- multiple myeloma, low-grade non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or a solid tumor (breast cancer, lung cancer, ovarian cancer);
- anemia;
- low erythropoietin levels;
- receiving anti-tumor therapy.
Exclusion criteria:
- poorly controlled hypertension;
- relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug;
- treatment with erythropoietin within the last 6 weeks;
- 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: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
- Plovdiv
- Sofia
- Stara Zagora
- Varna
