Evaluation of Cardiotoxic Effects of Bortezomib

NCT ID: NCT02026505

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-01

Study Completion Date

2019-03-01

Brief Summary

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The purpose of this study is to learn more about how a drug commonly used to treat multiple myeloma can affect the heart.

In this study, the investigators will learn whether a drug called how a drug (called bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of the standard treatment and its effects on multiple myeloma is not being studied here.

The investigators want to learn whether damage occurs to the heart after taking bortezomib for multiple myeloma, whether it is reversible, and we can predict damage to the heart before it occurs.

Detailed Description

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Conditions

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Multiple Myeloma Heart Failure, Systolic Cardiotoxins

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Myeloma, Bortezomib

Bortezomib

Intervention Type DRUG

Interventions

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Bortezomib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosis of multiple myeloma
* have a treatment plan involving greater than 4 cycles of bortezomib-based chemotherapy

Exclusion Criteria

* pre-existing history of left ventricular systolic dysfunction
* congestive heart failure
* coronary artery disease
* significant valvular heart disease
* cardiac arrhythmias
* estimated glomerular filtration rate \<30 mL/min/1.73m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millennium: The Takeda Oncology Company

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Stephen Heitner

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRB00010254

Identifier Type: -

Identifier Source: org_study_id

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