Daratumumab/Daratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis: a Prospective, Multicenter, Single-arm Study

Inclusion Criteria:

1. Age: 18-80 years old, diagnosed with primary amyloidosis of AL tissue;

2. ECOG PS score 0-2 points;

3. Measurable disease: The difference between affected and unaffected FLC is>20 mg/L,and the serum immunoglobulin kappa λ FLC ratio is abnormal;

4. Having sufficient organ and bone marrow function, defined as follows:

5. Blood routine: Absolute neutrophil count ≥ 1.0 x 10 ^ 9/L, platelet count ≥ 50x 10 ^ 9/L;

6. Blood biochemistry and electrolytes: ALT and AST both ≤ 3 times the upper limitof normal, total bilirubin ≤ 1.5 times the upper limit of normal, creatinineclearance rate ≥ 30 mL/min, serum corrected calcium ≤ 14.0 mg/dL (≤ 3.5 mmol/L)or free ion calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L);

7. Women of childbearing age must agree to use contraceptive measures (such asintrauterine devices, contraceptives, or condoms) during the study period and within 3 months after the end of the study; Within 7 days prior to enrollment in the study,the serum or urine pregnancy test was negative and must be a non lactating patient;In addition, if the subject misses their menstrual period or experiences abnormalmenstrual bleeding, the researcher can conduct a pregnancy trial at any time duringthe study period;

8. Men must agree to use contraceptive measures during the study period and within 3months after the end of the study period;

9. The patient agrees to participate in the clinical trial and signs an informedconsent form.

Exclusion Criteria:

1. Non AL amyloidosis;

2. Known to be allergic, hypersensitive or intolerant to monoclonal antibodies or humanderived proteins, daretozumab or its excipients, or known to be allergic tomammalian derivatives;

3. Female patients who have tested positive for lactation or serum pregnancy testduring the screening period;

4. Received ASCT or had graft-versus-host disease in the past 12 months;

5. Suffering from moderate or severe persistent asthma within 2 years prior toenrollment, or having uncontrolled asthma at the time of enrollment;

6. Evidence of having other malignant tumors within the 3 years prior to enrollment orhaving been previously diagnosed with another malignant tumor with any residuallesions;

7. Suffering from chronic obstructive pulmonary disease (COPD), the forced expiratoryvolume (FEV1) in one second is less than 50% of the normal expected value;

8. Clinically significant heart disease, including:

9. Start studying myocardial infarction or unstable or uncontrollable conditionswithin 6 months prior to treatment (such as unstable angina, congestive heartfailure, New York Heart Association (NYHA) III-IV);

10. Arrhythmias (NCI CTCAE V5.0 standard ≥ grade 3) or clinically significantelectrocardiogram (ECG) abnormalities;

11. The electrocardiogram shows a baseline corrected QT (QTc) interval>470 ms;

12. Active infections, including but not limited to HAV, HBV, HCV, HIV;

13. Plasma cell leukemia (circulating plasma cells>2.0 × 10 ^ 9/L) or Waldenstrommacroglobulinemia (WM) or POEMS syndrome (multiple neuropathies, organ enlargement,endocrine disorders, monoclonal plasma cell disease, and skin changes);

14. Peripheral neuropathy or neuralgia of grade 2 or above (CTCAE 5.0 standard);

15. Underwent major surgery within 14 days prior to enrollment, or did not fully recoverfrom early surgery, or planned surgery during the study period or within 14 daysafter the last study drug treatment (note: does not include surgery under localanesthesia or kyphoplasty or vertebroplasty);

16. According to the judgment of the investigator, there are concomitant diseases (suchas active systemic infection, uncontrolled diabetes, acute diffuse invasivepulmonary disease, neurological or mental disease, etc.) or any other conditionsthat may confuse the research results or affect the completion of the study;

17. Individuals who are receiving any other experimental drugs or experimental medicaldevices;

18. The researchers believe that the patient has other circumstances that are notsuitable for participation in this study.