Actively Recruiting
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
Led by Yongyong MA · Updated on 2024-06-12
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old with diagnosed primary AL amyloidosis
- ECOG performance status score of 0 to 2
- Measurable disease with affected and unaffected free light chain difference over 20 mg/L and abnormal serum immunoglobulin kappa/lambda ratio
- Adequate organ and bone marrow function, including neutrophil count 6 1.0 x 10^9/L, platelet count 6 50 x 10^9/L
- Liver enzymes ALT and AST 3 times upper limit of normal, total bilirubin 1.5 times upper limit of normal
- Creatinine clearance rate 6 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 during the study and 3 months after, have negative pregnancy tests before enrollment, and be non-lactating
- Men must agree to use contraceptive measures during the study and 3 months after
- Willingness to participate and provide signed informed consent
You will not qualify if you...
- Diagnosis other than AL amyloidosis
- Allergy or intolerance to monoclonal antibodies, human proteins, Daratumumab, or mammalian derivatives
- Positive lactation or pregnancy test during screening
- Prior autologous stem cell transplant or graft-versus-host disease within 12 months
- Moderate or severe persistent asthma in past 2 years or uncontrolled asthma currently
- Other malignant tumors diagnosed within 3 years or residual lesions from previous cancers
- Chronic obstructive pulmonary disease with FEV1 less than 50% of normal
- Significant heart disease including recent myocardial infarction, unstable angina, heart failure NYHA III-IV, severe arrhythmias, or prolonged QT interval
- Active infections including HAV, HBV, HCV, HIV
- Diagnosed plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS syndrome
- Peripheral neuropathy or neuralgia grade 2 or higher
- Major surgery within 14 days before enrollment or planned surgery during study or within 14 days after last treatment
- Other significant diseases or conditions that may affect study results or completion
- Current use of other experimental drugs or medical devices
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
Y
Yongyong Ma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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