Cardiac Toxicity and Prognostic Value of New Echocardiographic Indicators in the Treatment of Primary Multiple Myeloma

Обзор

Multiple myeloma (MM) is a malignant proliferative plasma cell disease, which accounts for approximately 10% and ranks secondly of hematological malignancies in many countries. It is more common in the middle-aged and elderly, and currently cannot be healed. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS) showed the quantitative definition table for cancer related cardiovascular toxicity (CTR-CVT) related to cancer treatment, which is crucial for understanding and balancing the absolute benefits of cancer treatment before and during treatment, including the implementation of primary preventive treatment, optimization of pre-existing cardiovascular diseases, dosage, frequency, and duration of tumor treatment, occurrence and severity of cardiovascular complications during treatment, as well as overall cumulative treatment received, time after treatment, and interactions with other cardiovascular diseases. However, current researches on adverse cardiac events in MM treatment mostly focus on follow-up of the therapeutic effects of certain drugs or comparison of short-term small sample ultrasound changes, but lacking systematic follow-up monitoring after treatment and the establishment of predictive models based on echocardiographic indicators. This study aims to find the monitoring indicators in the early stage that are more sensitive in anti-tumor therapy for multiple myeloma patients by monitoring the changes in echocardiographic indicators after therapy. Based on the prognosis and adverse event occurrence in multiple myeloma patients, a predictive model for combining new ultrasound indicators with anti-tumor therapy for cardiac damage events and prognosis is established.

Подробное описание

Multiple myeloma (MM) is a malignant proliferative plasma cell disease, which accounts for approximately 10% and ranks secondly of hematological malignancies in many countries. It is more common in the middle-aged and elderly, and currently cannot be healed.

2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS) showed the quantitative definition table for cancer related cardiovascular toxicity (CTR-CVT) related to cancer treatment, which is crucial for understanding and balancing the absolute benefits of cancer treatment before and during treatment, including the implementation of primary preventive treatment, optimization of pre-existing cardiovascular diseases, dosage, frequency, and duration of tumor treatment, occurrence and severity of cardiovascular complications during treatment, as well as overall cumulative treatment received, time after treatment, and interactions with other cardiovascular diseases. However, current researches on adverse cardiac events in MM treatment mostly focus on follow-up of the therapeutic effects of certain drugs or comparison of short-term small sample ultrasound changes, but lacking systematic follow-up monitoring after treatment and the establishment of predictive models based on echocardiographic indicators.

This study aims to find the monitoring indicators in the early stage that are more sensitive in anti-tumor therapy for multiple myeloma patients by monitoring the changes in echocardiographic indicators after therapy. The investigators plan to collect the clinical examination and echocardiographic images in the baseline and 3/6/12/36/60 months after treatment. After offline measurement, the investigators can get the changes of the structural and functional parameters, such as diameters, volumes, ejection fraction and strain of ventricle and atrium. Based on the prognosis and adverse event occurrence in multiple myeloma patients, a predictive model for combining new ultrasound indicators with anti-tumor therapy for cardiac damage events and prognosis is established.

Вмешательства

• Другое Chemotherapy and/or autologous hematopoietic stem cell transplantation
  Didn't interfere patients' treatment plan. Patients with chemotherapy (lenalidomide,bortezomib and dexamethasone) and/or autologous hematopoietic stem cell transplantation(ASCT) which is assessed by clinical doctors and only conventional treatments were used

Первичные конечные точки

• Impaired systolic function of left ventricle or potential myocardial injury [Срок оценки: During the study period and follow-up with 3/6/12/36/60 months]
• Impaired systolic function of left ventricle [Срок оценки: During the study period and follow-up with 3/6/12/36/60 months]

Критерии участия

Критерии включения

• Age 18-70 years old
• Patients diagnosed multiple myeloma by bone marrow cytology
• Trends to be hospitalized and treated by RVd induction therapy
• Be able to complete at least 3-4 cycles treatment

Критерии исключения

• Simultaneously diagnosed myocardial amyloidosis or other systemic amyloidosis
• Severe cardiovascular diseases such as myocardial infarction, heart failure, or previous surgery such as bypass grafting or valve replacement
• Severe arrhythmia such as atrial fibrillation
• Poor echocardiographic image quality

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Qilu hospital of Shandong university — Цзинань

Публикации

• Cowan AJ, Green DJ, Kwok M, Lee S, Coffey DG, Holmberg LA, Tuazon S, Gopal AK, Libby EN. Diagnosis and Management of Multiple Myeloma: A Review. JAMA. 2022 Feb 1;327(5):464-477. doi: 10.1001/jama.2022.0003. PMID 35103762
• Erratum: 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS): Developed by the task force on cardio-oncology of the European Society of Cardiology (ESC). Eur Heart J Cardiovasc Imaging. 2023 May 31;24(6):e98. doi: 10 PMID 37076917
• Bishnoi R, Xie Z, Shah C, Bian J, Murthy HS, Wingard JR, Farhadfar N. Real-world experience of carfilzomib-associated cardiovascular adverse events: SEER-Medicare data set analysis. Cancer Med. 2021 Jan;10(1):70-78. doi: 10.1002/cam4.3568. Epub 2020 Nov 10. PMID 33169938
• Das A, Dasgupta S, Gong Y, Shah UA, Fradley MG, Cheng RK, Roy B, Guha A. Cardiotoxicity as an adverse effect of immunomodulatory drugs and proteasome inhibitors in multiple myeloma: A network meta-analysis of randomized clinical trials. Hematol Oncol. 2022 Apr;40(2):233-242. doi: 10.1002/hon.2959. Epub 2021 Dec 30. PMID 34940983
• Nakao S, Uchida M, Satoki A, Okamoto K, Uesawa Y, Shimizu T. Evaluation of Cardiac Adverse Events Associated with Carfilzomib Using a Japanese Real-World Database. Oncology. 2022;100(1):60-64. doi: 10.1159/000519687. Epub 2021 Oct 21. PMID 34673654
• Buck B, Kellett E, Addison D, Vallakati A. Carfilzomib-induced Cardiotoxicity: An Analysis of the FDA Adverse Event Reporting System (FAERS). J Saudi Heart Assoc. 2022 Aug 31;34(3):134-141. doi: 10.37616/2212-5043.1311. eCollection 2022. PMID 36127934
• Liu Z, Zhang L, Liu M, Wang F, Xiong Y, Tang Z, Li Q, Lu Q, Liang S, Niu T, Huang H. Myocardial Injury in Multiple Myeloma Patients With Preserved Left Ventricular Ejection Fraction: Noninvasive Left Ventricular Pressure-Strain Myocardial Work. Front Cardiovasc Med. 2022 Jan 20;8:782580. doi: 10.3389/fcvm.2021.782580. eCollection 2021. PMID 35127857

Идентификаторы

NCT: NCT06039735 · KYLL-202306-015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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