A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
- Registration Number
- NCT02564094
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Adults at least 18 years of age
- Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
- Anemia with low erythropoeitin (EPO) levels
Exclusion Criteria
- Poorly controlled hypertension
- Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
- Treatment with EPO within the last 6 weeks
- Pregnant or breastfeeding females
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epoetin beta Epoetin beta Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.
- Primary Outcome Measures
Name Time Method Predictive value of reticulocyte increase At Week 2 Response rate according to hemoglobin level At Week 4 Transfusion requirement rate From Weeks 5 to 12
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to approximately 6 months