A Study of the Quality of Life and Treatment Response to Once Weekly Epoetin Beta (Recormon) Treatment in Anemic Participants With Solid and Lymphoid Malignancies

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00776425

ML20197

Details and patient eligibility

About

This 2 arm study will investigate Quality of Life response in anemic participants with solid and lymphoid malignancies, who are receiving concomitant chemotherapy. Participants with solid and lymphoid malignancies will receive epoetin beta at a dose of 150 international units per kilogram (IU/kg) three times weekly. Participants with lymphoid malignancies will receive epoetin beta 30000 IU once weekly.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anemia and prescribed treatment with epoetin beta
• Confirmed diagnosis of a solid or lymphoid hematologic malignancy
• Receiving or scheduled to receive chemotherapy
• Life expectancy of greater than or equal to (>=6) months

Exclusion criteria

• Anemia after bleeding, hemolytic anemia, megaloblastic anemia, anemia in chronic kidney failure, lever and endocrinology diseases
• Contraindications to epoetin beta
• Administration of epoetin beta during chemotherapy (e.g., on the third day after chemotherapy cycle start)
• Bleeding within one month before and/or during study
• Severe infection within one month before and/or during study
• Inability of participant to fill the questionnaires

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Epoetin Beta 150 IU/kg

Experimental group

Description:

Participants with solid and lymphoid malignancies will receive subcutaneous or intravenous epoetin beta at a dose of 150 IU per kg of body weight thrice weekly.

Treatment:

Drug: Epoetin beta

Epoetin Beta 30000 IU

Experimental group

Description:

Participants with lymphoid malignancies will receive subcutaneous or intravenous epoetin beta at a dose of 30000 IU once weekly.

Treatment:

Drug: Epoetin beta