Heart FailurePROTECTNCT02178579
Prospective Observation of Cardiac Safety With Proteasome Inhibition
An observational study of Heart Failure and Multiple Myeloma, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to better define and understand potential cardiac toxicities of proteasome inhibitors and to understand optimal management strategies to treat and prevent cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Multiple Myeloma
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to 15 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple Myeloma patients being treated with bortezomib or carfilzomib, per oncology physician decision.
Who may be able to join
- Relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care
- Received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
- Males and females ≥ 18 years of age
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines
Who cannot join
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Known or suspected AL amyloidosis, secondary amyloidosis or cardiac amyloidosis
- Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
- Waldenström Macroglobulinemia
- Myelodysplastic syndrome
- History of MI within the last 3 months
Show all 9Show fewer
- Symptomatic unstable cardiac arrhythmia requiring treatment in the past 3 months
- Class 3 or 4 New York Heart Association Heart Failure in the past 3 months
- Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pennsylvania/Smilow Center for Translational Research
Philadelphia, Pennsylvania, 19104-5159
About this study
The purpose of this study is to better define and understand potential cardiac toxicities of proteasome inhibitors and to understand optimal management strategies to treat and prevent cardiovascular events.
Read the detailed description
Cancer treatments, using proteasome inhibitors, have the potential in induce cardiac toxicities including heart failure (HF), hypertension, arrhythmias and ischemic heart disease. While the presence of cardiac events may be a class effect of proteasome inhibitors (PI), the effect may be more profound with the irreversible inhibition of carfilzomib compared with reversible inhibition with bortezomib. Data available from currently published clinical trials may be inadequate to fully understand the incidence and severity of cardiac injury in patients treated with proteasome inhibitors because the trials were not designed to fully assess cardiac events. The purpose of this study is to better define and understand potential cardiac toxicity and begin to understand optimal management strategies.
- Conditions
- Heart Failure, Multiple Myeloma
- Keywords
- Heart Failure, Cardiac Toxicity, Multiple Myeloma, Bortezomib, Carfilzomib
- Medical subject headings
- Heart Failure, Multiple Myeloma, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma (MM) treatment with bortezomib | No intervention planned. | |
| Multiple Myeloma (MM) treatment with carfilzomib | No intervention planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of cardiac events of patients receiving PIs for MM.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startNov 2014
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Robert F Cornell, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178579
- Sponsor's protocol ID
- 140404
- Acronym
- PROTECT
- Status last verified
- Sep 2020
- First submitted
- 26 Jun 2014
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There are no plans to share individual participant data.
Publications
Cornell RF, Ky B, Weiss BM, Dahm CN, Gupta DK, Du L, Carver JR, Cohen AD, Engelhardt BG, Garfall AL, Goodman SA, Harrell SL, Kassim AA, Jadhav T, Jagasia M, Moslehi J, O'Quinn R, Savona MR, Slosky D, Smith A, Stadtmauer EA, Vogl DT, Waxman A, Lenihan D. Prospective Study of Cardiac Events During Proteasome Inhibitor Therapy for Relapsed Multiple Myeloma. J Clin Oncol. 2019 Aug 1;37(22):1946-1955. doi: 10.1200/JCO.19.00231. Epub 2019 Jun 12.
PubMed 31188726
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation of Cardiac Safety With Proteasome Inhibition
- ClinicalTrials.gov ID
- NCT02178579
- Acronym / sponsor ID
- PROTECT / 140404
- Conditions
- Heart Failure, Multiple Myeloma
- Keywords
- Heart Failure, Cardiac Toxicity, Multiple Myeloma, Bortezomib, Carfilzomib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Nov 2014 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 1 Jul 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 better define and understand potential cardiac toxicities of proteasome inhibitors and to understand optimal management strategies to treat and prevent cardiovascular events.
Detailed description
Cancer treatments, using proteasome inhibitors, have the potential in induce cardiac toxicities including heart failure (HF), hypertension, arrhythmias and ischemic heart disease. While the presence of cardiac events may be a class effect of proteasome inhibitors (PI), the effect may be more profound with the irreversible inhibition of carfilzomib compared with reversible inhibition with bortezomib. Data available from currently published clinical trials may be inadequate to fully understand the incidence and severity of cardiac injury in patients treated with proteasome inhibitors because the trials were not designed to fully assess cardiac events. The purpose of this study is to better define and understand potential cardiac toxicity and begin to understand optimal management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma (MM) treatment with bortezomib | – | –No intervention planned. |
| Multiple Myeloma (MM) treatment with carfilzomib | – | –No intervention planned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Myeloma patients being treated with bortezomib or carfilzomib, per oncology physician decision.
Key inclusion criteria (4 listed)
- Relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care
- Received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
- Males and females ≥ 18 years of age
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines
Key exclusion criteria (9 listed)
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Known or suspected AL amyloidosis, secondary amyloidosis or cardiac amyloidosis
- Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
- Waldenström Macroglobulinemia
- Myelodysplastic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of cardiac events of patients receiving PIs for MM.
Time frame: 18 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 14 Sep 2020.
- Derived from this study: PubMed 31188726Cornell RF, Ky B, Weiss BM, Dahm CN, Gupta DK, Du L, Carver JR, Cohen AD, Engelhardt BG, Garfall AL, Goodman SA, Harrell SL, Kassim AA, Jadhav T, Jagasia M, Moslehi J, O'Quinn R, Savona MR, Slosky D, Smith A, Stadtmauer EA, Vogl DT, Waxman A, Lenihan D. Prospective Study of Cardiac Events During Proteasome Inhibitor Therapy for Relapsed Multiple Myeloma. J Clin Oncol. 2019 Aug 1;37(22):1946-1955. doi: 10.1200/JCO.19.00231. Epub 2019 Jun 12.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Robert F Cornell, MD principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Multiple Myeloma, run by Vanderbilt University Medical Center at 2 sites in United States.
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 4 inclusion and 9 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 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Frequency of cardiac events of patients receiving PIs for MM. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178579, which also lists 1 linked publication.
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 14 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.