xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06039735</url>
    </required_header>
    <id_info>
      <org_study_id>KYLL-202306-015</org_study_id>
      <nct_id>NCT06039735</nct_id>
    </id_info>
    <brief_title>Cardiac Toxicity and Prognostic Value of New Echocardiographic Indicators in the Treatment of Primary Multiple Myeloma</brief_title>
    <official_title>Cardiac Toxicity and Prognostic Value of New Echocardiographic Indicators in the Treatment of Primary Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Hospital of Shandong University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Multiple myeloma (MM) is a malignant proliferative plasma cell disease, which accounts for&#xD;
        approximately 10% and ranks secondly of hematological malignancies in many countries. It is&#xD;
        more common in the middle-aged and elderly, and currently cannot be healed.&#xD;
  &#xD;
        2022 ESC Guidelines on cardio-oncology developed in collaboration with the European&#xD;
        Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology&#xD;
        (ESTRO) and the International Cardio-Oncology Society (IC-OS) showed the quantitative&#xD;
        definition table for cancer related cardiovascular toxicity (CTR-CVT) related to cancer&#xD;
        treatment, which is crucial for understanding and balancing the absolute benefits of cancer&#xD;
        treatment before and during treatment, including the implementation of primary preventive&#xD;
        treatment, optimization of pre-existing cardiovascular diseases, dosage, frequency, and&#xD;
        duration of tumor treatment, occurrence and severity of cardiovascular complications during&#xD;
        treatment, as well as overall cumulative treatment received, time after treatment, and&#xD;
        interactions with other cardiovascular diseases. However, current researches on adverse&#xD;
        cardiac events in MM treatment mostly focus on follow-up of the therapeutic effects of&#xD;
        certain drugs or comparison of short-term small sample ultrasound changes, but lacking&#xD;
        systematic follow-up monitoring after treatment and the establishment of predictive models&#xD;
        based on echocardiographic indicators.&#xD;
  &#xD;
        This study aims to find the monitoring indicators in the early stage that are more sensitive&#xD;
        in anti-tumor therapy for multiple myeloma patients by monitoring the changes in&#xD;
        echocardiographic indicators after therapy. Based on the prognosis and adverse event&#xD;
        occurrence in multiple myeloma patients, a predictive model for combining new ultrasound&#xD;
        indicators with anti-tumor therapy for cardiac damage events and prognosis is established.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple myeloma (MM) is a malignant proliferative plasma cell disease, which accounts for&#xD;
        approximately 10% and ranks secondly of hematological malignancies in many countries. It is&#xD;
        more common in the middle-aged and elderly, and currently cannot be healed.&#xD;
  &#xD;
        2022 ESC Guidelines on cardio-oncology developed in collaboration with the European&#xD;
        Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology&#xD;
        (ESTRO) and the International Cardio-Oncology Society (IC-OS) showed the quantitative&#xD;
        definition table for cancer related cardiovascular toxicity (CTR-CVT) related to cancer&#xD;
        treatment, which is crucial for understanding and balancing the absolute benefits of cancer&#xD;
        treatment before and during treatment, including the implementation of primary preventive&#xD;
        treatment, optimization of pre-existing cardiovascular diseases, dosage, frequency, and&#xD;
        duration of tumor treatment, occurrence and severity of cardiovascular complications during&#xD;
        treatment, as well as overall cumulative treatment received, time after treatment, and&#xD;
        interactions with other cardiovascular diseases. However, current researches on adverse&#xD;
        cardiac events in MM treatment mostly focus on follow-up of the therapeutic effects of&#xD;
        certain drugs or comparison of short-term small sample ultrasound changes, but lacking&#xD;
        systematic follow-up monitoring after treatment and the establishment of predictive models&#xD;
        based on echocardiographic indicators.&#xD;
  &#xD;
        This study aims to find the monitoring indicators in the early stage that are more sensitive&#xD;
        in anti-tumor therapy for multiple myeloma patients by monitoring the changes in&#xD;
        echocardiographic indicators after therapy. We plan to collect the clinical examination and&#xD;
        echocardiographic images in the baseline and 3/6/12/36/60 months after treatment. After&#xD;
        offline measurement, we can get the changes of the structural and functional parameters, such&#xD;
        as diameters, volumes, ejection fraction and strain of ventricle and atrium. Based on the&#xD;
        prognosis and adverse event occurrence in multiple myeloma patients, a predictive model for&#xD;
        combining new ultrasound indicators with anti-tumor therapy for cardiac damage events and&#xD;
        prognosis is established.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Impaired systolic function of left ventricle or potential myocardial injury</measure>
      <time_frame>During the study period and follow-up with 3/6/12/36/60 months</time_frame>
      <description>LVEF≥50%, with a decrease of more than 15% in GLS compared with baseline, with/without an increase in diagnosed cardiac markers (cTnI/cTnT&gt;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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impaired systolic function of left ventricle</measure>
      <time_frame>During the study period and follow-up with 3/6/12/36/60 months</time_frame>
      <description>Newly diagnosed LVEF&lt;40%</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Patients diagnosed with previous untreated multiple myeloma</arm_group_label>
      <description>Patients diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Chemotherapy and/or autologous hematopoietic stem cell transplantation</intervention_name>
      <description>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</description>
      <arm_group_label>Patients diagnosed with previous untreated multiple myeloma</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged 18-70 years old diagnosed multiple myeloma by bone marrow cytology without&#xD;
          previous chemotherapy and/or hematopoietic stem cell transplantation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-70 years old&#xD;
  &#xD;
            2. Patients diagnosed multiple myeloma by bone marrow cytology&#xD;
  &#xD;
            3. Trends to be hospitalized and treated by RVd induction therapy&#xD;
  &#xD;
            4. Be able to complete at least 3-4 cycles treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Simultaneously diagnosed myocardial amyloidosis or other systemic amyloidosis&#xD;
  &#xD;
            2. Severe cardiovascular diseases such as myocardial infarction, heart failure, or&#xD;
               previous surgery such as bypass grafting or valve replacement&#xD;
  &#xD;
            3. Severe arrhythmia such as atrial fibrillation&#xD;
  &#xD;
            4. Poor echocardiographic image quality&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yu Zhang, Dr.</last_name>
      <phone>+86-0531-82166271</phone>
      <email>zhangyu_505@126.com</email>
    </overall_contact>
    <results_reference>
      <citation>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.</citation>
      <PMID>35103762</PMID>
    </results_reference>
    <results_reference>
      <citation>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: 10.1093/ehjci/jead080. No abstract available.</citation>
      <PMID>37076917</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>33169938</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>34940983</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>34673654</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>36127934</PMID>
    </results_reference>
    <results_reference>
      <citation>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.</citation>
      <PMID>35127857</PMID>
    </results_reference>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Multiple Myeloma</keyword>
    <keyword>Echocardiography</keyword>
    <keyword>Oncocardiology</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
      <mesh_term>Cardiotoxicity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This study is a single center study and don't plan to share with others</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06039735
  org study id: KYLL-202306-015
  nct id: NCT06039735
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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. We plan to collect the clinical examination and
        echocardiographic images in the baseline and 3/6/12/36/60 months after treatment. After
        offline measurement, we 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.
  observational model: Cohort
  time perspective: Prospective
  measure: Impaired systolic function of left ventricle or potential myocardial injury
  time frame: During the study period and follow-up with 3/6/12/36/60 months
  description: 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
  measure: Impaired systolic function of left ventricle
  time frame: During the study period and follow-up with 3/6/12/36/60 months
  description: Newly diagnosed LVEF<40%
  arm group label: Patients diagnosed with previous untreated multiple myeloma
  description: Patients diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation
  intervention type: Other
  intervention name: Chemotherapy and/or autologous hematopoietic stem cell transplantation
  description: 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
  arm group label: Patients diagnosed with previous untreated multiple myeloma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Yu Zhang, Dr.
  phone: +86-0531-82166271
  email: zhangyu_505@126.com
  citation: 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
  citation: 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: 10.1093/ehjci/jead080. No abstract available.
  PMID: 37076917
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  mesh term: Cardiotoxicity
  sharing ipd: No
  ipd description: This study is a single center study and don't plan to share with others