Evaluation of Cardiotoxic Effects of Bortezomib

March 11, 2019 updated by: Stephen Heitner, Oregon Health and Science University

Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (>18 years and <70 years) with multiple myeloma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple Myeloma, Bortezomib
Drug: Bortezomib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global longitudinal strain by echocardiography
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of late gadolinium enhancement by cardiac MRI
Time Frame: 6 months
6 months
High-sensitivity troponin T
Time Frame: 6 months
6 months
C-reactive protein
Time Frame: 6 months
6 months
Serum NT-proBNP
Time Frame: 6 months
6 months
Carboxyl-terminal telopeptide of collagen type I
Time Frame: 6 months
6 months
Amino-terminal peptide of procollagen type III
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Millennium: The Takeda Oncology Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00010254

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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