Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease

March 1, 2024 updated by: Beijing Chao Yang Hospital

A Cross-sectional Study on the Efficacy and Safety of the Combination of Daratumumab+Bortezomib+Dexamethasone Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease

It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, single arm, observational clinical study.It is expected to include 40 patients with M-protein related cardiac disease, who will sign informed consent forms. Collect baseline examination, treatment period (planned 6 cycles), and follow-up period (survival follow-up) data for patients who meet the inclusion and exclusion criteria. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone: subcutaneous injection of 1800mg of Daratumumab, d1, 8,15,22 (28 day cycle); (After 2 cycles of improvement in cardiac indicators, it can be adjusted to intravenous injection of daratumumab); Bortezomib 1.3 mg/m2 d1, 8, 15, 22; D1, 8, 15, 22; Dexamethasone 20 mg d1, 2, 8, 9, 15, 16, 22, 23. When NTProBNP is greater than 5400ng/ml, bortezomib 1.0mg/m2; When NTProBNP is greater than 8500ng/ml, bortezomib is 0.7mg/m2. When NTProBNP is greater than 10000ng/ml, bortezomib is temporarily not allowed; NTProBNP greater than 4500ng/ml dexamethasone starts at 10 mg/dose. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

Study Type

Observational

Enrollment (Estimated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Observe patient data from Beijing Chaoyang Hospital affiliated with Capital Medical University, Beijing Chuiyangliu Hospital, and Beijing Boren Hospital.

Description

Inclusion Criteria:

  • M-protein related cardiac disease aged 18 and above (at least one of the following criteria is met): (1) Systemic amyloidosis of the affected heart; (2) Presence of M component and presence of arrhythmia, cardiac enzyme abnormalities, cardiac function abnormalities, and exclusion of other diagnosable cardiac diseases;
  • ECOG score 0-2;
  • Sign a written informed consent form.

Exclusion Criteria:

  • Acute myocardial infarction;
  • Severe functional abnormalities in important organs such as lungs, liver, and kidneys (the carbon monoxide diffusion ability caused by chronic respiratory diseases is 50% lower than expected);
  • Major surgery, radiation therapy, infections requiring systemic antibiotic treatment, or other serious infections within 14 days after enrollment;
  • Individuals with mental illness, comprehension disorders, or other reasons that make it difficult to control themselves;
  • Pregnant or lactating women, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial. If the patient is male, refuse to use adequate contraceptive methods or donate semen during the study period and within 3 months after receiving the last cycle of drug study;
  • Diagnosed or treated another malignant tumor within 2 years prior to enrollment;
  • Individuals with allergies to daratumumab, bortezomib, or dexamethasone components or more severe allergic constitutions;
  • HIV infected individuals (HIV antibody positive);
  • Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen positive and/or hepatitis B core antibody positive, hepatitis B virus DNA more than 1x103 copies/mL; hepatitis C virus RNA more than 1x103 copies/mL);
  • Participate in another clinical trial 30 days after the start of the trial and throughout the entire trial period;
  • The researcher determined that patients who are not suitable to participate in this study;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
newly diagnosed M-protein related cardiac disease group
M-protein related cardiac disease aged 18 and above (at least one of the following criteria is met): (1) Systemic amyloidosis of the affected heart; (2) Presence of M component and presence of arrhythmia, cardiac enzyme abnormalities, cardiac function abnormalities, and exclusion of other diagnosable cardiac diseases. It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).
Drug: Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin
The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone: subcutaneous injection of 1800mg of Daratumumab, d1, 8,15,22 (28 day cycle); (After 2 cycles of improvement in cardiac indicators, it can be adjusted to intravenous injection of daratumumab); Bortezomib 1.3 mg/m2 d1, 8, 15, 22; D1, 8, 15, 22; Dexamethasone 20 mg d1, 2, 8, 9, 15, 16, 22, 23. When NTProBNP is greater than 5400ng/ml, bortezomib 1.0mg/m2; When NTProBNP is greater than 8500ng/ml, bortezomib is 0.7mg/m2. When NTProBNP is greater than 10000ng/ml, bortezomib is temporarily not allowed; NTProBNP greater than 4500ng/ml dexamethasone starts at 10 mg/dose. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: After 6 cycles of treatment (28 days as 1 cycle)
The percentage of cases that achieved complete response (CR) and partial response (PR) after treatment compared to the total evaluable cases.
After 6 cycles of treatment (28 days as 1 cycle)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year PFS rate, progression free survival (PFS)
Time Frame: Treatment for 2 years
The time interval from enrollment to objective observation of disease progression or death (caused by any reason).
Treatment for 2 years
2-year OS rate, overall survival (OS)
Time Frame: Treatment for 2 years
The time from enrollment to death due to any reason. For non deceased subjects, the cut-off date will be the last known survival date of the subjects.
Treatment for 2 years
Duration of Relief (DOR)
Time Frame: Treatment for 2 years
The time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause.
Treatment for 2 years
Next treatment time (TTNT)
Time Frame: Treatment for 2 years
The time interval from enrollment to receiving subsequent treatment.
Treatment for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Collaborators

Beijing Boren Hospital
Beijing Chuiyangliu Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1-27-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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