Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy
Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Anaemia and functional iron deficiency are common conditions in Multiple Myeloma (MM)
patients, conditions which reduce significantly the quality of life and increase morbidity
and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but
recently their use has been shown to have a negative impact on overall survival in different
oncology populations. Recently published data suggest that intravenous (IV) iron can be
effective in anaemia treatment, even without ESAs. This exploratory study is the first
clinical project with ferric carboxymaltose (FCM) in patients with MM: the data generated may
be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of
IV iron as FCM will be administered on the same day or within 24 hours before or after
chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM given
without ESA, in the correction of haemoglobin levels in subjects with MM, undergoing
chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and
the effect of FCM treatment on iron status variables in MM subjects.