A Study of Mircera in Anemic Patients With Multiple Myeloma
Status:
Completed
Trial end date:
2003-04-29
Target enrollment:
Participant gender:
Summary
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.