Evaluation of Cardiotoxic Effects of Bortezomib

NCT02026505 | Completed DMC

• 1 other identifier: IRB00010254
• Study Type: observational
• Target: 11
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma; Heart Failure, Systolic; Cardiotoxins

Outcome Measures

Primary Outcomes (1)

• Global longitudinal strain by echocardiography

  6 months

Secondary Outcomes (6)

• Amount of late gadolinium enhancement by cardiac MRI

  6 months

• High-sensitivity troponin T

  6 months

• C-reactive protein

  6 months

• Serum NT-proBNP

  6 months

• Carboxyl-terminal telopeptide of collagen type I

  6 months

Study Arms (1)

Multiple Myeloma, Bortezomib

Drug: Bortezomib

Interventions

Bortezomib DRUG

Multiple Myeloma, Bortezomib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Millennium: The Takeda Oncology Company: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and serum for batch analysis. Once the assays have been completed, the samples will be discarded.

MeSH Terms

Conditions

Multiple Myeloma; Heart Failure, Systolic

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Heart Failure; Heart Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 3, 2014
• Study Start: March 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: March 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03