Spots Global Cancer Trial Database for Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy

Study Description

Brief 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.

Detailed Description: Patients will be randomised into two groups. One will receive active FCM treatment and the other group will receive local standard of care. Active treatment group: Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the first scheduled chemotherapy cycle or within 24 hours before or after receiving chemotherapy. In subjects of weight ≤66 kg, the first dose (500 mg) will be administered on the day of the first scheduled chemotherapy cycle and the second dose (500 mg) on the next study visit. Standard of care group: Subjects will be treated according to the local institutional practice if requiring management of symptomatic anaemia. Intravenous iron should only be used to treat absolute iron deficiency (as defined as ferritin less than the lower limit of normal based on the test reference ranges). Patients with absolute iron deficiency are not eligible for inclusion to the study. Rescue medication to manage anaemia is permitted in both arms at the discretion of the treating physician and/or per institutional practice.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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