non-myeloid malignancies associated with chemotherapy induced anaemia (CIA). MedDRA version: 12.1 Level: LLT Classification code 10064014 Term: Cancer anemia
Conditions
Interventions
Trade Name: MonoFer 100 mg/ml
Product Name: MonoFer 100 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Iron isomaltoside 1000
Other descriptive name: Iron isomalto-oligosacchari
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women, aged more than 18 years. 2. Subjects diagnosed with non-myeloid malignancies ( including all solid tumors, Low Grade Lymphoma (LGL), Chronic Lymphatic Leukemia (CLL) and Myeloma) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles 3. Hb =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Anaemia caused primarily by other factors than CIA. 2. IV or oral iron treatment within 4 weeks prior to screening visit. 3. Erythrypoietin treatment within 4 weeks prior to screening visit. 4. Blood transfusion within 4 weeks prior to screening visit. 5. Imminent expectation of blood transfusion on part of treating physician. 6. Iron overload or disturbances in enrolment of iron (e.g. haemochromatosis and haemosiderosis). 7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate). 8. Known hypersensitivity to any excipients in the investigational drug products. 9. Subjects with a history of multiple allergies. 10. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit). 11. History of Immunocompromise and/or history of Hepatitis B and/or C. 12. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)). 13. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 14. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches). 15. Planned elective surgery during the study. 16. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening. 17. Known intolerance to oral iron treatment. 18. Untreated B12 or folate deficiency. 19. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in the ability to increase haemoglobin (Hb) in patients with chemotherapy induced anemia and either absolute or functional iron deficiency.;Secondary Objective: • To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®) for the correction of CIA in subjects with non-myeloid malignancies. • To compare study drug related adverse events after iron isomaltoside 1000 (Monofer®) to study drug related adverse events in subjects treated with oral iron sulfate. • To compare iron related hematological parameters (hemoglobin (Hb), transferrin saturation (TfS), serum iron, and serum ferritin levels). • To assess subjects who discontinue study due to lack of response or intolerance. • To assess Quality of Life. • Assessment of RLS symptoms and change in these symptoms during the study. • To detect the impact of the study drug upon the ability to complete the planned chemotherapy • To detect the impact of the study drug upon response to the chemotherapy;Primary end point(s): Change in Hb concentration from baseline to week 12. | — |
Countries
Denmark, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed