NCT06455748 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
| NCT ID | NCT06455748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yongyong MA |
| Condition | Amyloid Light-chain Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-01-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.
Eligibility Criteria
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: 1. Blood routine: Absolute neutrophil count ≥ 1.0 x 10 \^ 9/L, platelet count ≥ 50 x 10 \^ 9/L; 2. Blood biochemistry and electrolytes: ALT and AST both ≤ 3 times the upper limit of normal, total bilirubin ≤ 1.5 times the upper limit of normal, creatinine clearance 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); 5. Women of childbearing age must agree to use contraceptive measures (such as intrauterine 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 pregn