A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B

Roche

Status and phase: Terminated; Phase 4

Conditions: Anemia

Treatments: Drug: Epoetin Beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT02608060

ML18055

Details and patient eligibility

About

This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 individuals.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
• Anemia at Screening Visit

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Epoetin Beta - 30000 IU

Experimental group

Description:

Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.

Treatment:

Drug: Epoetin Beta