Multiple MyelomaNCT02026505
Evaluation of Cardiotoxic Effects of Bortezomib
An observational study of Multiple Myeloma and Heart Failure, Systolic, run by Oregon Health and Science University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, Heart Failure, Systolic, Cardiotoxins
- What is being tested?
- Bortezomib
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>18 years and <70 years) with multiple myeloma
Who may be able to join
- diagnosis of multiple myeloma
- have a treatment plan involving greater than 4 cycles of bortezomib-based chemotherapy
Who cannot join
- 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
About this study
Official title: Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma
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
- Being tested
- Bortezomib
- Medical subject headings
- Multiple Myeloma, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma, Bortezomib | Not described Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global longitudinal strain by echocardiography
Measured: 6 months
Secondary outcomes (6)
Amount of late gadolinium enhancement by cardiac MRI
Measured: 6 months
High-sensitivity troponin T
Measured: 6 months
C-reactive protein
Measured: 6 months
Serum NT-proBNP
Measured: 6 months
Carboxyl-terminal telopeptide of collagen type I
Measured: 6 months
Amino-terminal peptide of procollagen type III
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study start1 Mar 2014
- Primary completion31 Dec 2016
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company
- Responsible party
- Principal investigator, Stephen Heitner, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026505
- Sponsor's protocol ID
- IRB00010254
- Status last verified
- Mar 2019
- First submitted
- 18 Dec 2013
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02026505
- Acronym / sponsor ID
- IRB00010254
- Conditions
- Multiple Myeloma, Heart Failure, Systolic, Cardiotoxins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Millennium: The Takeda Oncology Company
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma, Bortezomib | – | Drug: Bortezomib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years and <70 years) with multiple myeloma
Key inclusion criteria (2 listed)
- diagnosis of multiple myeloma
- have a treatment plan involving greater than 4 cycles of bortezomib-based chemotherapy
Key exclusion criteria (6 listed)
- pre-existing history of left ventricular systolic dysfunction
- congestive heart failure
- coronary artery disease
- significant valvular heart disease
- cardiac arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib | Drug | Multiple Myeloma, Bortezomib |
Primary outcome
Global longitudinal strain by echocardiography
Time frame: 6 months
6 secondary outcomes
Amount of late gadolinium enhancement by cardiac MRI
Time frame: 6 months
High-sensitivity troponin T
Time frame: 6 months
C-reactive protein
Time frame: 6 months
Serum NT-proBNP
Time frame: 6 months
Carboxyl-terminal telopeptide of collagen type I
Time frame: 6 months
Amino-terminal peptide of procollagen type III
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Heart Failure, Systolic, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global longitudinal strain by echocardiography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.