An observational study in Multiple Myeloma, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Qilu Hospital of Shandong University · Observational
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18-70 years old diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation
Exclusion Criteria:
Patients diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation
Other: 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
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
Time frame: During the study period and follow-up with 3/6/12/36/60 months
Impaired systolic function of left ventricle
Newly diagnosed LVEF\<40%
Time frame: During the study period and follow-up with 3/6/12/36/60 months
Plan to share: No — This study is a single center study and don't plan to share with others
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Qilu Hospital of Shandong University