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Evaluation of Cardiotoxic Effects of Bortezomib

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02026505
Enrollment
11
Registered
2014-01-03
Start date
2014-03-01
Completion date
2019-03-01
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxins, Heart Failure, Systolic, Multiple Myeloma

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.

Interventions

DRUGBortezomib

Sponsors

Millennium: The Takeda Oncology Company
CollaboratorINDUSTRY
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Global longitudinal strain by echocardiography6 months

Secondary

MeasureTime frame
High-sensitivity troponin T6 months
C-reactive protein6 months
Amount of late gadolinium enhancement by cardiac MRI6 months
Carboxyl-terminal telopeptide of collagen type I6 months
Amino-terminal peptide of procollagen type III6 months
Serum NT-proBNP6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026