Clinical trial NCT01101399 (phase 3, status: completed)
Conditions: iron-deficiency anemia
ICD codes: D50.9, D50.0
Drugs: ferric carboxymaltose
SMILES: [Fe]
Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  8.5 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.

        Exclusion Criteria:

          -  Any anaemia treatment within 4 weeks before inclusion (including red blood cell
             transfusion, ESA treatment and any oral/parenteral iron supplementation).

          -  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.

          -  Significant cardiovascular disease prior to study inclusion including myocardial
             infarction within 12 months prior to study inclusion, congestive heart failure New
             York Heart Association (NYHA) 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).

          -  Females who are evidently pregnant (e.g., positive HCG test) or are 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.