A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02564094

ML18043

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Epoetin beta

Experimental group

Description:

Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.

Treatment:

Drug: Epoetin beta