KCT0003604
Completed
未知
Frontline lenalidomide for AL amyloidosis involving myocardium: Investigation of organ reversing capacity of lenalidomide
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Status
- Completed
- Enrollment
- 2
Overview
Brief Summary
.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •? Age more than 19 years old
- •? Amyloid light\-chain amyloidosis patients who meet both(A and B) of the following critetia
- •A. Cardiac involvement: meet one or more of the following criteria
- •a. Echocardiography : mean wall thickness \> 12mm, and no other cardiac cause
- •b. Cardiac MRI : CMR was considered positive for amyloid cardiomyopathy if there were morphologic and structural abnormalities consistent with the diagnosis (wall thickening of the left ventricular \[LV], right ventricular \[RV], or
- •interatrial septum and biatrial enlargement) coupled with abnormal myocardial nulling and diffuse or irregular delayed gadoliniumenhancement of the LV myocardium.
- •c. N\-terminal prohormone of brain natriuretic peptide : \> 332ng/l in the absence pf renal failure
- •B. Exposure history to lenalidomide: participants should have never been exposed to lenalidomide within 5 years.
- •? Eastern Cooperative Oncology Group performance status \= 3
- •? Patients must meet the following clinical laboratory criteria with 2 weeks of starting treatment:
Exclusion Criteria
- •? Amyloid light\-chain amyloidosis without cardiac involvement
- •? Patients who are planning to receive autologous stem cell transplantation or received autologous stem cell transplantation, remained in hematologic complete response
- •? Pregnant, lactating or unwilling to use adequate contraception
- •? Male patients who unwilling to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study treatment
- •? Patients with acute infections requiring nonpermanent therapy (antibiotics, antibacterial drugs, or antiviral drugs) within 14 days of the first administration of the lenalidomide or with a history of systemic fungal infections and infections without valid antimicrobial agents
- •? Any clinically significant history of genetic, kidney, neurological, psychiatric, endocrine, metabolism, immunological, cardiovascular, lung, or liver diseases in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
- •? Patients with known history of allergic and hypersensitivity for investigational product, their analogous bodies, or the subtypes contained in the various forms of any preparation
- •? Patients who were given a live vaccine within 8 weeks of the first dose of the drug
- •? Chemotherapy with approved or investigation anticancer therapeutics within 4 weeks prior to starting this study
- •? Patients who are unable to voluntarily agree to participate in a study or who are not willing to participate
Investigators
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