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Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy (AOC-MM)

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ClinicalTrials.gov Identifier: NCT01100879
Recruitment Status : Terminated (Lack of Recruitment)
First Posted : April 9, 2010
Last Update Posted : October 12, 2011
Sponsor:
Information provided by:
Vifor Inc.

March 29, 2010
April 9, 2010
October 12, 2011
March 2010
July 2011   (Final data collection date for primary outcome measure)
Change in haemoglobin from baseline to Week 8 [ Time Frame: week 8 post baseline ]
Same as current
Complete list of historical versions of study NCT01100879 on ClinicalTrials.gov Archive Site
  • The percentage of subjects with blood haemoglobin increase of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment. [ Time Frame: 12 weeks post baseline ]
  • Change in haemoglobin from baseline to Week 4 [ Time Frame: week 4 post baseline ]
  • Change in haemoglobin from baseline to Week 6 [ Time Frame: week 6 post baseline ]
Same as current
Not Provided
Not Provided
 
Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy
Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Multiple Myeloma & Iron Restricted Erythropoiesis Receiving Chemotherapy
Anaemia and functional iron deficiency are common conditions in Multiple Myeloma (MM) patients, conditions which reduce significantly the quality of life and increase morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but recently their use has been shown to have a negative impact on overall survival in different oncology populations. Recently published data suggest that intravenous (IV) iron can be effective in anaemia treatment, even without ESAs. This exploratory study is the first clinical project with ferric carboxymaltose (FCM) in patients with MM: the data generated may be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM given without ESA, in the correction of haemoglobin levels in subjects with MM, undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and the effect of FCM treatment on iron status variables in MM subjects.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Iron-Deficiency Anemia
Drug: Ferric carboxymaltose

Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.

Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 3 (Week 2).

Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.

Other Name: Ferinject
  • Active Comparator: Ferric carboxymaltose
    Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 3 (week 2).
    Intervention: Drug: Ferric carboxymaltose
  • No Intervention: Local standard of care.
    Subjects will be treated according to the local institutional practice.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
Same as current
October 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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"
  • Subjects with progressed/relapsed MM should have had stable disease (during the last 6 months since prior treatment).
  • Life expectancy at least 6 months.
  • 8.5 g/dL ≤Hb ≤11 g/dL at time of randomisation.
  • 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%
  • Females of child-bearing potential must have a negative urine pregnancy test at screening.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

  • Any anaemia treatment within 4 weeks prior to randomisation (including red blood cell transfusions, treatment with ESA or any oral/parenteral iron preparations).
  • Anthracycline containing chemotherapy regimens.
  • Subjects weighing <35 kg.
  • Folate deficiency (serum-folate <4.5 nmol/L) and/or Vitamin B12 deficiency (serum-cobalamin <145 pmol/L).
  • Ongoing haemolysis defined as serum-haptoglobin <0.2 g/L.
  • Known chronic renal failure, glomerular filtration rate <30 mL/min/m2.
  • Recent (within last 4 weeks) significant bleeding/surgery, defined as drop in Hb of ≥2 g/dL.
  • Clinically relevant active inflammatory disease other than MM (according to the judgement of the Investigator).
  • Clinically relevant ongoing infectious disease including known human immunodeficiency virus.
  • Serum ferritin >600 ng/mL.
  • Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia.
  • 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.
  • Elevation of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 3 times above the normal range or known acute hepatic disorder.
  • 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).
  • Subject of child-bearing potential is evidently pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.
  • 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.
  • Subject has known sensitivity to any of the products to be administered during dosing.
  • Subject will not be available for follow-up assessment.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Greece
 
 
NCT01100879
FER-AOC-MM
No
Not Provided
Not Provided
Nicola Waddingham / Clinical Operations Manager, Vifor Pharma
Vifor Inc.
Not Provided
Principal Investigator: Katodritou Eirini, MD Theagenion Hospital, Thessaloniki, Greece
Study Director: Timothy R Cushway Vifor Pharma, CH-8152 Glattbrugg, Switzerland
Vifor Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP