Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy

NCT01101399 | Completed Phase 3

• 1 other identifier: FER-FID-CHEMO
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 2

Brief Summary

Anaemia and functional iron deficiency are common conditions in patients with lymphoid malignancies, 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 lymphoid malignancies: 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 in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies, undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and the effect of FCM treatment on iron status variables in subjects suffering from lymphoid malignancies.

Conditions

Iron-Deficiency Anemia

Keywords

Anemia; Lymphoproliferative Disorders; Chemotherapy; ferric carboxymaltose; iron

Outcome Measures

Primary Outcomes (1)

• Change in haemoglobin from baseline to Week 4

  Weeks 4 post baseline

Secondary Outcomes (3)

• 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 6

  6 weeks after baseline

• Change in haemoglobin from baseline to Week 8

  8 weeks after baseline

Study Arms (2)

Ferric carboxymaltose

ACTIVE COMPARATOR

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 4 (week 2).

Drug: Ferric carboxymaltose

Local standard of care.

NO INTERVENTION

Subjects will be treated according to the local institutional practice.

Interventions

Ferric carboxymaltose DRUG

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 4 (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.

Also known as: Ferinject

Ferric carboxymaltose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects (male or female) aged ≥18, suffering from indolent non-Hodgkin's lymphoma, multiple myeloma or chronic lymphocytic leukaemia on any chemotherapy excluding anthracycline containing.
• Life expectancy at least 6 months.
• Received at least 12 weeks (or 3 cycles) of treatment in the current course of chemotherapy before start of iron therapy.
• g/dL Hb 10.5 g/dL at time of randomisation.
• Iron-restricted erythropoiesis as defined:
• Stainable iron in bone marrow combined with transferrin saturation (TSAT) ≤20% OR
• where the evaluation of stainable iron in bone marrow is not possible or available:
• ferritin \>30 ng/mL (women) or \>40 ng/mL (men) and
• TSAT ≤20%
• Signed informed consent (before any study procedure).
• Females of child-bearing potential must have a negative urine pregnancy test.

You may not qualify if:

• Subjects weighing \<35 kg.
• Subjects with increase in Hb during the chemotherapy (\>1 g/dL rise between initiation of CT and screening laboratory value).
• 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.
• Recent significant bleeding/surgery.
• Monotherapy with immunotherapy agents.
• Known chronic renal failure, creatinine \>125 μmol/L.
• Anthracycline containing chemotherapy regimens.
• Clinically relevant active inflammatory disease other than the malignant disease (according to the judgement of the Investigator).
• Clinically relevant ongoing infectious disease including known human immunodeficiency virus.
• Serum-ferritin \>800 ng/mL.
• Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia.
• 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).
• Females who are evidently pregnant (e.g., positive HCG test) or are breast feeding.

Sponsors & Collaborators

• Vifor Pharma: lead

Study Sites (2)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Department of Medicine, St Görans Hospital (Capio St Görans Sjukhus)

Stockholm, SE-112 81, Sweden

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia; Lymphoproliferative Disorders

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Torbjörn Karlsson, MD, PhD

  Capio St Görans Sjukhus, Stockholm

  PRINCIPAL INVESTIGATOR

• Morgan McNamara

  Vifor Pharma, CH-8152 Glattbrugg, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 9, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2013
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

SE (1); DE (1)