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

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

Sponsors

Lead sponsor: Vifor (International) Inc.

Source Vifor (International) Inc.
Brief 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.

Overall Status Terminated
Start Date March 2010
Completion Date October 2011
Primary Completion Date July 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in haemoglobin from baseline to Week 8 week 8 post baseline
Secondary Outcome
Measure Time Frame
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. 12 weeks post baseline
Change in haemoglobin from baseline to Week 4 week 4 post baseline
Change in haemoglobin from baseline to Week 6 week 6 post baseline
Enrollment 40
Condition
Intervention

Intervention type: Drug

Intervention name: Ferric carboxymaltose

Description: 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.

Arm group label: Ferric carboxymaltose

Other name: Ferinject

Eligibility

Criteria:

Inclusion Criteria:

- Subjects (male or female) aged ≥18, suffering from a newly diagnosed or progressed/relapsed MM and scheduled to receive anti-myeloma treatment. Progression is defined according to "Uniform Response Criteria for Multiple Myeloma"

- Subjects with progressed/relapsed MM should have had stable disease (during the last 6 months since prior treatment).

- Life expectancy at least 6 months.

- 8.5 g/dL ≤Hb ≤11 g/dL at time of randomisation.

- Iron-restricted erythropoiesis as defined:

- Stainable iron in bone marrow (BM) combined with transferrin saturation (TSAT) ≤20%, or

- where the evaluation of stainable iron in BM is not possible or available:

- ferritin >30 ng/mL (women) or >40 ng/mL (men), and

- TSAT ≤20%

- Females of child-bearing potential must have a negative urine pregnancy test at screening.

- Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

- Any anaemia treatment within 4 weeks prior to randomisation (including red blood cell transfusions, treatment with ESA or any oral/parenteral iron preparations).

- Anthracycline containing chemotherapy regimens.

- Subjects weighing <35 kg.

- Folate deficiency (serum-folate <4.5 nmol/L) and/or Vitamin B12 deficiency (serum-cobalamin <145 pmol/L).

- Ongoing haemolysis defined as serum-haptoglobin <0.2 g/L.

- Known chronic renal failure, glomerular filtration rate <30 mL/min/m2.

- Recent (within last 4 weeks) significant bleeding/surgery, defined as drop in Hb of ≥2 g/dL.

- Clinically relevant active inflammatory disease other than MM (according to the judgement of the Investigator).

- Clinically relevant ongoing infectious disease including known human immunodeficiency virus.

- Serum ferritin >600 ng/mL.

- Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia.

- Significant cardiovascular disease prior to study inclusion including myocardial infarction within 12 months prior to study inclusion, congestive heart failure New York Heart Association Grade III or IV, or poorly controlled hypertension according to the judgment of the Investigator.

- Elevation of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 3 times above the normal range or known acute hepatic disorder.

- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s).

- Subject of child-bearing potential is evidently pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.

- Subject is not using adequate contraceptive precautions. Adequate contraceptive precautions are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or post-menopausal, defined as amenorrhea for at least 12 months.

- Subject has known sensitivity to any of the products to be administered during dosing.

- Subject will not be available for follow-up assessment.

- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
Hopital Sud | Rennes, 35203, France
Theagenion Cancer Center | Thessaloniki, 54007, Greece
Location Countries

France

Greece

Verification Date

June 2011

Responsible Party

Name title: Nicola Waddingham / Clinical Operations Manager

Organization: Vifor Pharma

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Ferric carboxymaltose

Arm group type: Active Comparator

Description: 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).

Arm group label: Local standard of care.

Arm group type: No Intervention

Description: Subjects will be treated according to the local institutional practice.

Acronym AOC-MM
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov