light chain amyloidosis
Conditions
Interventions
Experimental group:daratumumab
Sponsors
The First Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. The patient (or his legal representative) signed the informed consent form, indicating that he understands the purpose and process requirements of the research and is willing to participate in this research; 2. Aged over 18 years, no gender limit; 3. The pathological biopsy of the accumulated system or organ (kidney, heart, liver, skin, etc.) of the primary disease is clearly AL amyloidosis, and other secondary factors are excluded; 4. Bone marrow or blood/urine fixation electrophoresis indicates monoclonal plasma cell proliferation; 5. Appearance of measurable serum and/or urine abnormal M protein or free light chain (dFLC>50mg/L).
Exclusion criteria
Exclusion criteria: 1. The abnormal proliferation of plasma cells reaches the standard of multiple myeloma or other hematological tumors; 2. Combined with glaucoma, severe osteoporosis, history of peptic ulcer/bleeding, mental disorders, Cushing syndrome and other related diseases that are contraindicated in the use of hormones; 3. Complicated with current infection, active hepatitis, tuberculosis or other underlying diseases for which the use of immunosuppressants is contraindicated; 4. Complicated with thrombosis or bleeding; 5. Patients who are pregnant or breastfeeding; 6. Have a history of allergies to the drugs used in clinical trials or have a history of acute or chronic allergies in the past 4 weeks; 7. Severe physical or mental illness that may interfere with this clinical study; 8. The investigator judges that the patient's compliance is not suitable for participating in this trial; 9. There is a past or current history of tumor, and there is a risk of tumor recurrence or metastasis; 10. Other circumstances that are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Countries
China
Contacts
Public ContactCai Zhen
The First Affiliated Hospital of Zhejiang University
Outcome results
None listed