NCT04407858

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2022

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

May 14, 2020

Last Update Submit

June 4, 2020

Conditions

MyelomaHeart FailureHypertension

Keywords

Adverse drug event

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (6)

  • Systemic hypertension

    6 months

  • Heart Failure Reduced Ejection Fraction

    6 months

  • Heart Failure Preserved Ejection Fraction

    6 months

  • Predictors of Cardiotoxicity

    6 months

  • Impact on outcomes

    1 year

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective cohort of patients starting carfilzomib treatment.

You may qualify if:

  • Intention to treat by Carfilzomib

You may not qualify if:

  • History of carfilzomib treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Centre Université de Paris

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma CellHeart FailureHypertensionDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHeart DiseasesCardiovascular DiseasesVascular DiseasesChemically-Induced Disorders

Study Officials

  • Mariana Mirabel

    Assistance Publique Hôpitaux de Paris - Université de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana Mirabel

CONTACT

+33156095636mariana.mirabel@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 29, 2020

Study Start

May 21, 2020

Primary Completion

May 21, 2021

Study Completion

May 21, 2022

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

FR(1)