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Completed

NCT Number: NCT02026505

Evaluation of Cardiotoxic Effects of Bortezomib

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

Primary outcomes

  1. Global longitudinal strain by echocardiography

    Time frame: 6 months

Secondary outcomes

  1. Amount of late gadolinium enhancement by cardiac MRI

    Time frame: 6 months

  2. High-sensitivity troponin T

    Time frame: 6 months

  3. C-reactive protein

    Time frame: 6 months

  4. Serum NT-proBNP

    Time frame: 6 months

  5. Carboxyl-terminal telopeptide of collagen type I

    Time frame: 6 months

  6. Amino-terminal peptide of procollagen type III

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Millennium: The Takeda Oncology Company

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Jan 3, 2014
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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