A Study of Mircera in Anemic Patients With Multiple Myeloma
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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.
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
Actual Study Start Date
November 29, 2001
Actual Primary Completion Date
April 29, 2003
Actual Study Completion Date
April 29, 2003
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
adult patients, >=18 years of age;
confirmed diagnosis of multiple myeloma;
anemia (hemoglobin <=11g/dL at screening visit).
transfusion of red blood cells during 2 months prior to first planned dose of study medication;
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.