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

Phase 4

Terminated

• Conditions: Anemia
• Interventions: Drug: Epoetin Beta

• Registration Number: NCT02608060
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin Beta - 30000 IU	Epoetin Beta	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin levels at 16 weeks	16 Weeks

Secondary Outcome Measures

Name	Time	Method
Time to Global Response	Up to 4 months
Serum Iron, Ferritin and Transferrin Levels	16 Weeks
Percentage of Participants with a Positive Response	Weeks 4 and 8
Quality of Life in Relation to Grade of Anemia	Up to 4 months
Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument	Up to 4 months
Tolerability - Incidence of Adverse Events	Up to 16 Weeks of treatment period