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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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;

• The patient agrees to participate in the clinical trial and signs an informed consent form.

Locations
Other Locations
China
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Yongyong Ma, MD
mayy@wmu.edu.cn
+86-13566281793
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 20
Treatments
Experimental: Daratumumab/daratumumab and hyaluronidase-fihj in combination with pomalidomide, dexamethasone (DPd)
Observed patients meeting the screening criteria were treated with Daratumumab/daratumumab and hyaluronidase-fihj + pomalidomide + dexamethasone regimen as appropriate.~Combined regimen of the above until disease progression or up to 2 years.
Related Therapeutic Areas
Sponsors
Leads: Yongyong MA

This content was sourced from clinicaltrials.gov

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