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
- Conditions
- Treatment of anaemic subjects with multiple myeloma and iron restricted erythropoiesis receiving chemotherapy.MedDRA version: 13.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1Level: PTClassification code 10049467Term: Erythropoiesis abnormalSystem Organ Class: 10005329 - Blood and lymphatic system disorders
- Registration Number
- EUCTR2009-015766-56-DE
- Lead Sponsor
- Vifor Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
available:
- 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method