drugset / Trial / NCT01100879

Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy

NCT01100879

Phase 4 Terminated 3 enrolled Vifor Pharma
RandomizedParallel-groupOpen-labelTreatment

Summary

Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of ferric carboxymaltose (FCM) in treatment of anaemia in subjects with multiple myeloma (MM) initiating chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion and randomised to receive intravenous infusions of FCM or standard care (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). Thereafter the visits are scheduled at Weeks 0, 2, 4, 6 and 8.

Timeline

Start
2010-03
Primary completion
2011-07
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric carboxymaltose Other / unclassified 500 mg Intravenous
Comparator Ferric carboxymaltose Other / unclassified 1000 mg Intravenous