MyelomaICARENCT04407858
Cardiovascular Complications of Carfilzomib
An observational study of Myeloma and Heart Failure, run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Heart Failure, Hypertension
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2020to 21 May 2022
- Phase
- Observational
- 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
Study population: Prospective cohort of patients starting carfilzomib treatment.
Who may be able to join
- Intention to treat by Carfilzomib
Who cannot join
- History of carfilzomib treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - Centre Université de Paris
Paris, 75015
Mariana Mirabel, MD, PhD, +33156095636, mariana.mirabel@aphp.fr
About this study
Official title: Insuffisance Cardiaque Sous Carfilzomib: étude Prospective
Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.
- Conditions
- Myeloma, Heart Failure, Hypertension
- Keywords
- Adverse drug event
- Medical subject headings
- Neoplasms, Plasma Cell, Heart Failure, Hypertension, Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardio-vasculo-toxicity of carfilzomib
Number of patients with cardio-toxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of carfilzomib.
Measured: 6 months
Secondary outcomes (6)
Systemic hypertension
Number of patients with as systemic hypertension
Measured: 6 months
Heart Failure Reduced Ejection Fraction
Number of patients with Heart Failure and Reduced Ejection Fraction
Measured: 6 months
Heart Failure Preserved Ejection Fraction
Number of patients with Heart Failure and Preserved Ejection Fraction
Measured: 6 months
Predictors of Cardiotoxicity
Correlation between cardio-vascular toxicity and patients' chacateristics.
Measured: 6 months
Impact on outcomes
Compare outcomes (mortality) in patients with cardiotoxicity and no cardiotoxicty.
Measured: 1 year
Safety
Compare outcomes (mortality) in patients with cardiotoxicity according to the continuation of carflzomib or its withdrawl.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start21 May 2020
- Primary completion21 May 2021 (estimated)
- Study completion21 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Mirabel, European Georges Pompidou Hospital
- Investigators
- Mariana Mirabel, Principal investigator, Assistance Publique Hôpitaux de Paris - Université de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407858
- Sponsor's protocol ID
- 00011928 ICARE
- Acronym
- ICARE
- Status last verified
- Jun 2020
- First submitted
- 14 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insuffisance Cardiaque Sous Carfilzomib: étude Prospective
- ClinicalTrials.gov ID
- NCT04407858
- Acronym / sponsor ID
- ICARE / 00011928 ICARE
- Conditions
- Myeloma, Heart Failure, Hypertension
- Keywords
- Adverse drug event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 21 May 2021 (estimated)
- Study completion
- 21 May 2022 (estimated)
- First posted
- 29 May 2020 (actual)
- 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.
Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort of patients starting carfilzomib treatment.
Key inclusion criteria (1 listed)
- Intention to treat by Carfilzomib
Key exclusion criteria (1 listed)
- History of carfilzomib treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cardio-vasculo-toxicity of carfilzomib
Time frame: 6 months
Number of patients with cardio-toxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of carfilzomib.
6 secondary outcomes
Systemic hypertension
Time frame: 6 months
Heart Failure Reduced Ejection Fraction
Time frame: 6 months
Heart Failure Preserved Ejection Fraction
Time frame: 6 months
Predictors of Cardiotoxicity
Time frame: 6 months
Impact on outcomes
Time frame: 1 year
Safety
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Mariana Mirabel principal investigator
Assistance Publique Hôpitaux de Paris - Université de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma and Heart Failure, run by European Georges Pompidou Hospital at 1 site in France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana Mirabel (+33156095636, mariana.mirabel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardio-vasculo-toxicity of carfilzomib (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2020.