Trial information
A Study of NeoRecormon (Epoetin Beta) for Treatment of Anemia in Patients With Hematologic Malignancies.
Status: Completed
Protocol number: ML17616
Sponsor: Shanghai Roche Pharmaceuticals Ltd.
Company division: Pharmaceutical
Official Scientific Title: Multicenter, open-label study of NeoRecormon treatment for anemia in adult patients with multiple myeloma, low-grade non-Hodgkin's lymphoma, or chronic lymphocytic leukemia with a relative erythropoietin deficiency, receiving anti-tumor chemotherapy
Brief summary: This study will evaluate the efficacy and safety of NeoRecormon for the treatment of anemia in patients with multiple myeloma, low-grade non-Hodgkin's lymphoma, or chronic lymphocytic leukemia who are receiving anti-tumor chemotherapy. Patients will receive either NeoRecormon or standard therapy (blood transfusion and iron supplement) 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: III
Study type: Interventional; Treatment; Open Label; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: percentage of patients with increase in hemoglobin values >=2g/dL without transfusion in the previous 6 weeks.
Key secondary outcomes: 1. Efficacy: Increase in hemoglobin; number and volume of blood transfusions; and levels of hematocrit, red blood cells, reticulocytes, and iron. Safety:adverse events, blood pressure and laboratory values.
Inclusion criteria:
- adult patients >=18 years of age;
- multiple myeloma, low-grade Non-Hodgkin's lymphoma, or chronic lymphocytic leukemia (ie hematologic malignancies) verified by cytologic or histologic examination;
- receiving anti-tumor chemotherapy for a duration of >=3 months.
Exclusion criteria:
- history of other malignancy;
- clinically relevant cardiovascular disease;
- acute or chronic bleeding within 3 months of study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/30/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Shanghai
- Tianjin
- Wuhan
- Xi'An
