EUCTR2009-015766-56-FR进行中（未招募）1 期
A randomised controlled parallel group open-label study to evaluate the efficacy and safety of intravenous ferric carboxymaltose versus no treatment in anaemic subjects with multiple myeloma and iron-restricted erythropoiesis receiving chemotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 pg
- •b) In case that evaluation of stainable iron in BM is not possible or available, subjects should have:
- •Ferritin >30 ng/mL (women) or >40 ng/mL (men) and
- •- HYPO% =5% or CHr <30 pg
- •combined with
- •- TSAT =25%.
- •6. Females of child-bearing potential must have a negative urine pregnancy test at screening.
- •7. Before any study-specific procedure, the appropriate written informed consent must be obtained.
- •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
排除标准
- •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 <35 kg.
- •4. Folate deficiency (serum-folate <4.5 nmol/L) and/or Vitamin B12 deficiency (serum-cobalamin <145 pmol/L).
- •5. Ongoing haemolysis defined as serum-haptoglobin <0.2 g/L.
- •6. Known chronic renal failure, glomerular filtration rate <30 mL/min/m2.
- •7. Recent (within last 4 weeks) significant bleeding/surgery, defined as drop in Hb of =2 g/dL.
- •8. Ongoing or recent history (within 6 months) of venous thromboembolism.
- •9. Clinically relevant active inflammatory disease other than MM (according to the judgement of the Investigator).
- •10. Clinically relevant ongoing infectious disease including known human immunodeficiency virus.
- •11. Serum ferritin >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.
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