EUCTR2009-015766-56-DE进行中（未招募）不适用
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
- 不适用
- 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).
- •FER-AOC-MM Page 5 of 74
- •4 December 2009
- •3. Life expectancy at least 6 months.
- •4. 8.5 g/dL =Hb =11 g/dL at time of randomisation.
- •5. Iron-restricted erythropoiesis as defined:
- •Stainable iron in bone marrow (BM) combined with transferrin
- •saturation (TSAT) =20%, or
- •where the evaluation of stainable iron in BM is not possible or
- •- ferritin >30 ng/mL (women) or >40 ng/mL (men), and
- •- TSAT =20%
- •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. Clinically relevant active inflammatory disease other than MM (according
- •to the judgement of the Investigator).
- •9. Clinically relevant ongoing infectious disease including known human
- •immunodeficiency virus.
- •10. Serum ferritin >600 ng/mL.
- •11. Ongoing significant neurological or psychiatric disorders including
- •psychotic disorders or dementia.
- •12. 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.
- •13. Elevation of liver enzymes (aspartate aminotransferase, alanine
- •aminotransferase) over 3 times above the normal range or known acute
- •hepatic disorder.
- •14. 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).
- •15. Subject of child-bearing potential is evidently pregnant (e.g., positive
- •human chorionic gonadotropin test) or is breast feeding.
- •16. 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.
- •17. Subject has known sensitivity to any of the products to be administered
- •during dosing.
- •18. Subject will not be available for follow-up assessment.
- •19. 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.
研究者
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