It is expected to include 40 patients with M-protein related cardiac disease. Thetreatment medication for enrolled patients must comply with the treatment regimen ofDaratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/dayat the beginning of treatment (creatinine clearance rate greater than 20ml/min).
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).
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).
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;
Not Provided
Not Provided