Iron-Deficiency AnemiaPhase 4AOC-MMNCT01100879

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

A Phase 4 study testing Ferric carboxymaltose in people with Iron-Deficiency Anemia, run by Vifor Pharma at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Iron-Deficiency Anemia
What is being tested?: Ferric carboxymaltose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 2 sitesin 2 countries
Study dates: Mar 2010to Oct 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

France1 site

Hopital Sud
Rennes, 35203

Other trials in France

Greece1 site

Theagenion Cancer Center
Thessaloniki, 54007

Other trials in Greece

About this study

Official title: 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

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.

Read the detailed description

Patients will be randomised into two groups. One will receive active FCM treatment and the other group will receive local standard of care.

Active treatment group: Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the first scheduled chemotherapy cycle or within 24 hours before or after receiving chemotherapy. In subjects of weight ≤66 kg, the first dose (500 mg) will be administered on the day of the first scheduled chemotherapy cycle and the second dose (500 mg) on the next study visit.

Standard of care group: Subjects will be treated according to the local institutional practice if requiring management of symptomatic anaemia. Intravenous iron should only be used to treat absolute iron deficiency (as defined as ferritin less than the lower limit of normal based on the test reference ranges). Patients with absolute iron deficiency are not eligible for inclusion to the study.

Rescue medication to manage anaemia is permitted in both arms at the discretion of the treating physician and/or per institutional practice.

Conditions: Iron-Deficiency Anemia
Being tested: Ferric carboxymaltose
Keywords: Anemia, Lymphoproliferative Disorders, Chemotherapy, ferric carboxymaltose, iron
Medical subject headings: Anemia, Iron-Deficiency, Anemia, Lymphoproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferric carboxymaltoseDrug
Also called Ferinject
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.

Study groups in NCT01100879
Study group	Role	What they receive
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). Receives: Drug: Ferric carboxymaltose
Local standard of care.	No intervention	Subjects will be treated according to the local institutional practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: week 4, 6 and 8 post baseline

Secondary outcomes (14)

Percentage of subjects with blood Hb response of at least 1 g/dL
Percentage of subjects with blood Hb response of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment.
Measured: 12 weeks post baseline
Percentage of subjects with a blood Hb correction to at least 12 g/dL
Percentage of subjects with a blood Hb correction to at least 12 g/dL in the absence of any red cell transfusion or ESA treatment
Measured: 12 weeks post baseline
Time to Hb response defined as increase in Hb equal to or more than 1 g/dL
Median time to Hb response defined as increase in Hb equal to or more than 1 g/dL in the absence of any red cell transfusion or ESA treatment
Measured: Baseline until end of study (week 8)
Subjects receiving red blood cell transfusions or subjects treated with ESA
Proportion of subjects receiving red blood cell transfusions or subjects treated with ESA during the study period
Measured: Baseline until end of study (week 8)
Adverse events
Adverse events: type, nature, incidence and outcome
Measured: Baseline until end of study (week 8)
Transfusion/treatment with ESA
Time to transfusion/treatment with ESA
Measured: Baseline until end of study (week 8)
Change in serum ferritin from baseline to Weeks 2, 4, 6 and 8
Mean change in serum ferritin from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline
Change in transferrin saturation (TSAT) from baseline to Weeks 2, 4, 6 and 8
Mean change in TSAT from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline
Change in serum iron from baseline to Weeks 2, 4, 6 and 8
Mean change in serum iron from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline
Change in endogenous erythropoietin from baseline to Weeks 2, 4, 6 and 8
Mean change in endogenous erythropoietin from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline
Change in blood reticulocyte haemoglobin content/red blood cell size factor from baseline to Weeks 2, 4, 6 and 8
Mean change in blood reticulocyte haemoglobin content/red blood cell size factor from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline
Change in percentage of hypochromic red cells/percentage of low Hb density from baseline to Weeks 2, 4, 6 and 8
Mean change in percentage of hypochromic red cells/percentage of low Hb density from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline
Change in hepcidin from baseline to Weeks 2, 4, 6 and 8
Mean change in hepcidin from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline
Change in interleukin-6 from baseline to Weeks 2, 4, 6 and 8
Mean change in interleukin-6 from baseline to Weeks 2, 4, 6 and 8
Measured: week 2, 4, 6, and 8 post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Oct 2011

First posted9 Apr 2010 (estimated)
Study startMar 2010
Primary completionJul 2011
Study completionOct 2011

Why it stopped: Lack of Recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Iron-Deficiency AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01100879
Sponsor's protocol ID: FER-AOC-MM
Acronym: AOC-MM
Status last verified: Jun 2011
First submitted: 29 Mar 2010
Last updated: 9 May 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention

All Iron-Deficiency Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01100879
Acronym / sponsor ID: AOC-MM / FER-AOC-MM
Conditions: Iron-Deficiency Anemia
Keywords: Anemia, Lymphoproliferative Disorders, Chemotherapy, ferric carboxymaltose, iron
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of Recruitment
Enrolment: 3 participants (actual)
Lead sponsor: Vifor PharmaIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jul 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 9 Apr 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients will be randomised into two groups. One will receive active FCM treatment and the other group will receive local standard of care.

Rescue medication to manage anaemia is permitted in both arms at the discretion of the treating physician and/or per institutional practice.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ferric carboxymaltose	Active comparator	Drug: Ferric carboxymaltoseSubjects 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).
Local standard of care.	No intervention	–Subjects will be treated according to the local institutional practice.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ferric carboxymaltoseAlso: FerinjectSubjects 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.	Drug	Ferric carboxymaltose

Primary outcome

Change in haemoglobin (Hb) from baseline to Weeks 4, 6 and 8
Time frame: week 4, 6 and 8 post baseline
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.

14 secondary outcomes

Percentage of subjects with blood Hb response of at least 1 g/dL
Time frame: 12 weeks post baseline
Percentage of subjects with a blood Hb correction to at least 12 g/dL
Time frame: 12 weeks post baseline
Time to Hb response defined as increase in Hb equal to or more than 1 g/dL
Time frame: Baseline until end of study (week 8)
Subjects receiving red blood cell transfusions or subjects treated with ESA
Time frame: Baseline until end of study (week 8)
Adverse events
Time frame: Baseline until end of study (week 8)
Transfusion/treatment with ESA
Time frame: Baseline until end of study (week 8)
Change in serum ferritin from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline
Change in transferrin saturation (TSAT) from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline
Change in serum iron from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline
Change in endogenous erythropoietin from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline
Change in blood reticulocyte haemoglobin content/red blood cell size factor from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline
Change in percentage of hypochromic red cells/percentage of low Hb density from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline
Change in hepcidin from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline
Change in interleukin-6 from baseline to Weeks 2, 4, 6 and 8
Time frame: week 2, 4, 6, and 8 post baseline

Results and safety

The study was stopped early (reason given: Lack of Recruitment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.

Related trials for Iron-Deficiency Anemia

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katodritou Eirini, MD principal investigator

Theagenion Hospital, Thessaloniki, Greece

Timothy R Cushway study director

Vifor Pharma, CH-8152 Glattbrugg, Switzerland

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferric carboxymaltose in people with Iron-Deficiency Anemia, run by Vifor Pharma at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of Recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in haemoglobin (Hb) from baseline to Weeks 4, 6 and 8 (time frame: week 4, 6 and 8 post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01100879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.