Treatment of anaemic subjects with multiple myeloma and iron restricted erythropoiesis receiving chemotherapy. MedDRA version: 12.0 Level: LLT Classification code 10028228 Term: Multiple myeloma MedDRA version: 12.0 Level: LLT Classification code 10049467 Term: Erythropoiesis abnormal
Conditions
Interventions
Trade Name: Ferinject®
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Ferric carboxymaltose (FCM)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrat
Sponsors
Vifor Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects (male or female) aged =18, suffering from a newly diagnosed or progressed/relapsed MM and scheduled to receive anti myeloma treatment. Progression is defined according to “Uniform Response Criteria for Multiple Myeloma”, please refer to Appendix 1. 2. Subjects with progressed/relapsed MM should have had stable disease (during the last 6 months since prior treatment). 3. Life expectancy at least 6 months. 4. 8.5 g/dL =Hb =11 g/dL at time of randomisation. 5. Iron restricted erythropoiesis defined as: a) Stainable iron in bone marrow (BM) combined with at least one of the following: • Transferrin saturation (TSAT) =25% • percentage of hypochromic red cells (HYPO%) =5% • blood reticulocyte haemoglobin content (CHr) 30 ng/mL (women) or >40 ng/mL (men) and - HYPO% =5% or CHr =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 prior to randomisation (including red blood cell transfusions, treatment with ESA or any oral/parenteral iron preparations). 2. Anthacycline containing chemotherapy regimens. 3. Subjects weighing 800 ng/mL. 12. Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia. 13. Significant cardiovascular disease prior to study inclusion including myocardial infarction within 12 months prior to study inclusion, congestive heart failure New York Heart Association Grade III or IV, or poorly controlled hypertension according to the judgment of the Investigator. 14. Elevation of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 3 times above the normal range or known acute hepatic disorder. 15. 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). 16. Subject of child-bearing potential is evidently pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding. 17. 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. 18. Subject has known sensitivity to any of the products to be administered during dosing. 19. Subject will not be available for follow-up assessment. 20. 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 |
|---|---|
| Main Objective: Evaluation of efficacy of FCM given without erythropoiesis stimulating agents (ESA) in the correction of haemoglobin (Hb) levels in subjects with multiple myeloma (MM), undergoing chemotherapy.;Secondary Objective: Describe safety and tolerability of FCM. Describe the effect of treatment with FCM on iron status variables in MM subjects. ;Primary end point(s): Primary Efficacy Endpoint: • 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. Secondary Endpoints: • The percentage of subjects with blood Hb response of at least 1 g/dL at any study week in the absence of any red cell transfusion or ESA treatment. • The percentage of subjects with a Hb correction to at least 12 g/dL in the absence of any red cell transfusion or ESA treatment. • The median time to Hb response defined as increase in Hb =1 g/dL in the absence of any red cell transfusion or ESA treatment. • The proportion of subjects receiving red blood cell transfusions or subjects treated with ESA during the study period. • Adverse events: type, nature, incidence and outcome. • Time to transfusion/treatment with ESA. • Change in iron variables from baseline to the Weeks 2, 4, 6, 8 (ferritin, TSAT, serum iron, endogenous erythropoetin, CHr, HYPO%). | — |
Countries
France, Germany, Greece
Outcome results
None listed