A Study of Mircera in Anemic Patients With Multiple Myeloma

Open Label, Randomized, Exploratory Study to Investigate the Hemoglobin Dose-response, the Safety and the Pharmacokinetic Profile Following Subcutaneous Administration of Mircera Once Every Three Weeks to Anemic Patients With Multiple Myeloma

This study will investigate the efficacy, safety and pharmacokinetics of Mircera in adult anemic patients with multiple myeloma. In the first stage of the study, patients will be randomized to receive subcutaneous injections of Mircera once every 3 weeks, at doses of 2.0, 3.5 or 5.0 micrograms/kg. Following the administration of 2 doses, an evaluation of hemoglobin increase will be made at week 6. In the second stage, further groups of patients will receive additional doses of Mircera,at doses of 1.0, 6.5 or 8.0 micrograms/kg, depending on efficacy, safety and pharmacokinetic considerations.The anticipated time on treatment is 3-12 months, and the target sample size is <100 individuals.

Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure

Inclusion Criteria: adult patients, >=18 years of age; confirmed diagnosis of multiple myeloma; anemia (hemoglobin <=11g/dL at screening visit). Exclusion Criteria: transfusion of red blood cells during 2 months prior to first planned dose of study medication; therapy-resistant hypertension; relevant acute or chronic bleeding within 3 months prior to planned start of study treatment; recombinant human erythropoietin or erythropoiesis-stimulating drug therapy within 3 months prior to planned start of study treatment.