Multiple MyelomaNCT06039735
Cardiac Toxicity and Prognostic Value of New Echocardiographic Indicators in the Treatment of Primary Multiple Myeloma
An observational study of Multiple Myeloma, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Chemotherapy and/or autologous hematopoietic stem cell transplantation
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2023to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-70 years old diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu hospital of Shandong university
Jinan, Shandong
Yu Zhang, Dr., +86-0531-82166217, zhangyu_505@126.com
About this study
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Chemotherapy and/or autologous hematopoietic stem cell transplantation
- Keywords
- Multiple Myeloma, Echocardiography, Oncocardiology
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy and/or autologous hematopoietic stem cell transplantationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with previous untreated multiple myeloma | Patients diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation Receives: Other: Chemotherapy and/or autologous hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the study period and follow-up with 3/6/12/36/60 months
Impaired systolic function of left ventricle
Newly diagnosed LVEF<40%
Measured: During the study period and follow-up with 3/6/12/36/60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start16 Nov 2023
- Primary completion16 Nov 2023
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039735
- Sponsor's protocol ID
- KYLL-202306-015
- Status last verified
- Apr 2023
- First submitted
- 10 Sep 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a single center study and don't plan to share with others
Publications
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.
PubMed 35103762Erratum: 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.
PubMed 37076917Bishnoi 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.
PubMed 33169938Das 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.
PubMed 34940983Nakao 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.
PubMed 34673654Buck 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.
PubMed 36127934Liu 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.
PubMed 35127857
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Toxicity and Prognostic Value of New Echocardiographic Indicators in the Treatment of Primary Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06039735
- Acronym / sponsor ID
- KYLL-202306-015
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Echocardiography, Oncocardiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with previous untreated multiple myeloma | – | Other: Chemotherapy and/or autologous hematopoietic stem cell transplantationPatients diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-70 years old diagnosed multiple myeloma by bone marrow cytology without previous chemotherapy and/or hematopoietic stem cell transplantation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy and/or autologous hematopoietic stem cell transplantationDidn'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 | Other | Patients diagnosed with previous untreated multiple myeloma |
Primary outcome
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
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
Impaired systolic function of left ventricle
Time frame: During the study period and follow-up with 3/6/12/36/60 months
Newly diagnosed LVEF<40%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Results publication: PubMed 35103762Cowan 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.
- Results publication: PubMed 37076917Erratum: 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.
- Results publication: PubMed 33169938Bishnoi 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.
- Results publication: PubMed 34940983Das 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.
- Results publication: PubMed 34673654Nakao 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.
- Results publication: PubMed 36127934Buck 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.
- Results publication: PubMed 35127857Liu 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.
- Individual participant dataSharing planned: No. This study is a single center study and don't plan to share with others
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, Dr. (+86-0531-82166271, zhangyu_505@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039735, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.