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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Myeloma (MM) treatment with bortezomib | No intervention planned. | ||
| Multiple Myeloma (MM) treatment with carfilzomib | No intervention planned. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of cardiac events of patients receiving PIs for MM. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple Myeloma patients being treated with bortezomib or carfilzomib, per oncology physician decision.
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| Name | Affiliation | Role |
|---|---|---|
| Robert F Cornell, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania/Smilow Center for Translational Research | Philadelphia | Pennsylvania | 19104-5159 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31188726 | Derived | 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. |
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There are no plans to share individual participant data.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009101 | Multiple Myeloma |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
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Blood sample banked for future research.
| Vanderbilt University Medical Center |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |