Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Lymphoid Malignancies & Functional Iron Deficiency Receiving Chemotherapy
- Subjects (male or female) aged ≥18, suffering from indolent non-Hodgkin's lymphoma,
multiple myeloma or chronic lymphocytic leukaemia on any chemotherapy excluding
- 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%
- where the evaluation of stainable iron in bone marrow is not possible or
- 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.
- 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
- 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
- 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
- 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.