drugset / Trial / NCT01100879
Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferric carboxymaltose | Other / unclassified | 500 mg | Intravenous |
| Comparator | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |