Cardiac Toxicity and Prognostic Value of New Echocardiographic Indicators in the Treatment of Primary Multiple Myeloma
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
November 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedNovember 21, 2023
April 1, 2023
Same day
September 10, 2023
November 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Impaired systolic function of left ventricle or potential myocardial injury
LVEF≥50%, with a decrease of more than 15% in GLS compared with baseline, with/without an increase in diagnosed cardiac markers (cTnI/cTnT\>99 percentile, BNP≥35pg/mL, NT-proBNP≥125pg/mL or significantly increased compared to baseline);Newly LVEF decreased more than 10% compared with baseline and is 40-49%; or newly LVEF decreased less than 10% and is 40-49%, accompanied by a decrease of more than 15% in GLS or an increase in one of the diagnosed cardiac markers including cTnI/cTnT, BNP and NT-proBNP mentioned above compared with baseline
During the study period and follow-up with 3/6/12/36/60 months
Impaired systolic function of left ventricle
Newly diagnosed LVEF\<40%
During the study period and follow-up with 3/6/12/36/60 months
Study Arms (1)
Patients diagnosed with previous untreated multiple myeloma
Patients diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation
Interventions
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
Eligibility Criteria
Patients aged 18-70 years old diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu hospital of Shandong university
Jinan, Shandong, China
Related Publications (7)
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: 35103762RESULTErratum: 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: 10.1093/ehjci/jead080. No abstract available.
PMID: 37076917RESULTBishnoi 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: 33169938RESULTDas 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: 34940983RESULTNakao 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: 34673654RESULTBuck 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: 36127934RESULTLiu 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: 35127857RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2023
First Posted
September 15, 2023
Study Start
November 16, 2023
Primary Completion
November 16, 2023
Study Completion (Estimated)
December 1, 2028
Last Updated
November 21, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
This study is a single center study and don't plan to share with others