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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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M-protein Related Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No