Anaemic subjects with lymphoid malignancies and functional iron deficiency receiving chemotherapy MedDRA version: 14.0 Level: LLT Classification code 10025631 Term: Malignant lymphoid neoplasm NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10002034 Term: Anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0 Level: PT Classification code 10022970
Conditions
Interventions
Trade Name: Ferinject®
Pharmaceutical Form:
INN or Proposed INN: Ferric carboxymaltose (FCM)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Sponsors
Vifor (International) AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Life expectancy at least 6 months. 3. Received at least 12 weeks (or 3 cycles) of treatment in the current course of chemotherapy before start of iron therapy. 4. 8.5 g/dL =Hb =10.5 g/dL at time of randomisation. 5. 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% 6. Signed informed consent (before any study procedure). 7. Females of child-bearing potential must have a negative urine pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any anaemia treatment within 4 weeks before inclusion (including red blood cell transfusion, ESA treatment and any oral/parenteral iron supplementation). 2. Subjects weighing 1 g/dL rise between initiation of CT and screening laboratory value). 4. Folate deficiency (serum folate 125 µmol/L. 9. Anthracycline containing chemotherapy regimens. 10. Clinically relevant active inflammatory disease other than the malignant disease (according to the judgement of the Investigator). 11. Clinically relevant ongoing infectious disease including known human immunodeficiency virus. 12. Serum-ferritin >800 ng/mL. 13. Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia. 14. 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. 15. Elevation of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 3 times above the normal range or known acute hepatic disorder. 16. 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). 17. Females who are evidently pregnant (e.g., positive HCG test) or are breast feeding. 18. 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. 19. Subject has known sensitivity to any of the products to be administered during dosing. 20. Subject will not be available for follow-up assessment. 21. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Mean change in Hb from baseline to Weeks 4, 6 and 8 (end of treatment) in the absence of any red cell transfusion or ESA treatment.;Main Objective: Evaluation of efficacy of Ferric carboxymaltose (FCM) given without erythropoiesis stimulating agents (ESA) in the correction of haemoglobin (Hb) levels in anaemic subjects with lymphoproliferative disorder (LPD), undergoing chemotherapy.;Secondary Objective: • Describe safety and tolerability of FCM. • Describe the effect of treatment with FCM on iron status variables in LPD subjects. | — |
Countries
Germany, Sweden
Outcome results
None listed