Evaluation of Cardiotoxic Effects of Bortezomib | NCT02026505

Studies
Evaluation of Cardiotoxic Effects of Bortezomib

NCT02026505

Sponsor

Oregon Health and Science University

Status

Completed

Last Update Posted

Mar 13, 2019Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Multiple Myeloma
Heart Failure, Systolic
Cardiotoxins

Interventions

Bortezomib

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2014Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Mar 1, 2019Actual

First Submitted Date

Dec 18, 2013

First Submission Date that Met QC Criteria

Dec 31, 2013

First Posted Date

Jan 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephen Heitner, Assistant Professor of Medicine, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Name	Class
Millennium: The Takeda Oncology Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

11Actual

Label	Type	Description	Intervention Names
Multiple Myeloma, Bortezomib			Drug: Bortezomib

Name	Type	Description	Arm Group Labels	Other Names
Bortezomib	Drug		Multiple Myeloma, Bortezomib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global longitudinal strain by echocardiography		6 months

Secondary Outcomes

Measure	Description	Time Frame
Amount of late gadolinium enhancement by cardiac MRI		6 months
High-sensitivity troponin T		6 months
C-reactive protein

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D054143	Heart Failure, Systolic

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069286	Bortezomib

Ancestor Terms

ID	Term
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided