Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy

NCT01100879 | Terminated Phase 4

• 1 other identifier: FER-AOC-MM
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 2

Brief Summary

Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of ferric carboxymaltose (FCM) in treatment of anaemia in subjects with multiple myeloma (MM) initiating chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion and randomised to receive intravenous infusions of FCM or standard care (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). Thereafter the visits are scheduled at Weeks 0, 2, 4, 6 and 8.

Conditions

Iron-Deficiency Anemia

Keywords

Anemia; Lymphoproliferative Disorders; Chemotherapy; ferric carboxymaltose; iron

Outcome Measures

Primary Outcomes (1)

• Change in haemoglobin (Hb) from baseline to Weeks 4, 6 and 8

  Mean change in Hb from baseline to Weeks 4, 6 and 8 (end of treatment) in the absence of any red cell transfusion or erythropoiesis stimulating agents (ESA) treatment.

  week 4, 6 and 8 post baseline

Secondary Outcomes (14)

• Percentage of subjects with blood Hb response of at least 1 g/dL

  12 weeks post baseline

• Percentage of subjects with a blood Hb correction to at least 12 g/dL

  12 weeks post baseline

• Time to Hb response defined as increase in Hb equal to or more than 1 g/dL

  Baseline until end of study (week 8)

• Subjects receiving red blood cell transfusions or subjects treated with ESA

  Baseline until end of study (week 8)

• Adverse events

  Baseline until end of study (week 8)

Study Arms (2)

Ferric carboxymaltose

ACTIVE COMPARATOR

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).

Drug: Ferric carboxymaltose

Local standard of care.

NO INTERVENTION

Subjects will be treated according to the local institutional practice.

Interventions

Ferric carboxymaltose DRUG

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.

Also known as: Ferinject

Ferric carboxymaltose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vifor Pharma: lead

Study Sites (2)

Hopital Sud

Rennes, 35203, France

Location

Theagenion Cancer Center

Thessaloniki, 54007, Greece

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia; Lymphoproliferative Disorders

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Katodritou Eirini, MD

  Theagenion Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Timothy R Cushway

  Vifor Pharma, CH-8152 Glattbrugg, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: April 9, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 9, 2022

Record last verified: 2011-06

Locations

FR (1); GR (1)