Daratumumab/Daratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone… (NCT06455748) | Clinical Trial Compass
RecruitingNot Applicable
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
China20 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age: 18-80 years old, diagnosed with primary amyloidosis of AL tissue;
✓. ECOG PS score 0-2 points;
✓. Measurable disease: The difference between affected and unaffected FLC is\>20 mg/L, and the serum immunoglobulin kappa λ FLC ratio is abnormal;
✓. Having sufficient organ and bone marrow function, defined as follows:
✓. Blood routine: Absolute neutrophil count ≥ 1.0 x 10 \^ 9/L, platelet count ≥ 50 x 10 \^ 9/L;
✓. 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);
✓. 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 pregnancy test was negative and must be a non lactating patient; In addition, if the subject misses their menstrual period or experiences abnormal menstrual bleeding, the researcher can conduct a pregnancy trial at any time during the study period;
✓. Men must agree to use contraceptive measures during the study period and within 3 months after the end of the study period;
Exclusion criteria
✕. Non AL amyloidosis;
✕
What they're measuring
1
Hematologic Overall Remission Rate (ORR)
Timeframe: A follow-up is required 30 days (± 7 days) after the completion of all treatments, followed by a follow-up every 12 weeks (± 7 days) for a period of 1 year.
. Known to be allergic, hypersensitive or intolerant to monoclonal antibodies or human derived proteins, daretozumab or its excipients, or known to be allergic to mammalian derivatives;
✕. Female patients who have tested positive for lactation or serum pregnancy test during the screening period;
✕. Received ASCT or had graft-versus-host disease in the past 12 months;
✕. Suffering from moderate or severe persistent asthma within 2 years prior to enrollment, or having uncontrolled asthma at the time of enrollment;
✕. Evidence of having other malignant tumors within the 3 years prior to enrollment or having been previously diagnosed with another malignant tumor with any residual lesions;
✕. Suffering from chronic obstructive pulmonary disease (COPD), the forced expiratory volume (FEV1) in one second is less than 50% of the normal expected value;