Clinical trial · Observational
Prospective Observation of Cardiac Safety With Proteasome Inhibition
NCT02178579CI-TRIAL-00047140PROTECTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heart Failure | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Multiple Myeloma (MM) treatment with bortezomib
- description
- No intervention planned.
- label
- Multiple Myeloma (MM) treatment with carfilzomib
- description
- No intervention planned.
Primary outcomes (1)
- measure
- Frequency of cardiac events of patients receiving PIs for MM.
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDCornell 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. PMID 31188726