Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy (AOC-MM)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Multiple Myeloma & Iron Restricted Erythropoiesis Receiving Chemotherapy|
- Change in haemoglobin from baseline to Week 8 [ Time Frame: week 8 post baseline ] [ Designated as safety issue: No ]
- The percentage of subjects with blood haemoglobin increase of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
- Change in haemoglobin from baseline to Week 4 [ Time Frame: week 4 post baseline ] [ Designated as safety issue: No ]
- Change in haemoglobin from baseline to Week 6 [ Time Frame: week 6 post baseline ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Ferric carboxymaltose
Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 3 (week 2).
Drug: Ferric carboxymaltose
Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.
Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 3 (Week 2).
Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.
Other Name: Ferinject
No Intervention: Local standard of care.
Subjects will be treated according to the local institutional practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100879
|Rennes, France, 35203|
|Theagenion Cancer Center|
|Thessaloniki, Greece, 54007|
|Principal Investigator:||Katodritou Eirini, MD||Theagenion Hospital, Thessaloniki, Greece|
|Study Director:||Timothy R Cushway||Vifor Pharma, CH-8152 Glattbrugg, Switzerland|