Evaluation of Cardiotoxic Effects of Bortezomib

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02026505
• Collaborator: Millennium: The Takeda Oncology Company (Industry)
• Enrollment: 11
• Actual Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Heart Failure, Systolic; Cardiotoxins	Drug: Bortezomib

Study Design

• Study Type: Observational
• Actual Enrollment: 11 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma
• Actual Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Multiple Myeloma, Bortezomib	Drug: Bortezomib

Outcome Measures

Primary Outcome Measures

1. Global longitudinal strain by echocardiography [6 months]

Secondary Outcome Measures

1. Amount of late gadolinium enhancement by cardiac MRI [6 months]

2. High-sensitivity troponin T [6 months]

3. C-reactive protein [6 months]

4. Serum NT-proBNP [6 months]

5. Carboxyl-terminal telopeptide of collagen type I [6 months]

6. Amino-terminal peptide of procollagen type III [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephen Heitner, Assistant Professor of Medicine, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT02026505
• Other Study ID Numbers: IRB00010254
• First Posted: Jan 3, 2014
• Last Update Posted: Mar 13, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Heart Failure, Systolic; Bortezomib

Study Results

No Results Posted as of Mar 13, 2019