Multiple Myeloma Clinical Trial
Official title:
Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma
| NCT number | NCT02026505 |
| Other study ID # | IRB00010254 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2014 |
| Est. completion date | March 1, 2019 |
| Verified date | March 2019 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | March 1, 2019 |
| Est. primary completion date | December 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University | Millennium: The Takeda Oncology Company |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Global longitudinal strain by echocardiography | 6 months | ||
| Secondary | Amount of late gadolinium enhancement by cardiac MRI | 6 months | ||
| Secondary | High-sensitivity troponin T | 6 months | ||
| Secondary | C-reactive protein | 6 months | ||
| Secondary | Serum NT-proBNP | 6 months | ||
| Secondary | Carboxyl-terminal telopeptide of collagen type I | 6 months | ||
| Secondary | Amino-terminal peptide of procollagen type III | 6 months |
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