This phase II clinical trial aimed at influencing the improvement of major organ functions, especially the objective response rate, in Amyloid light-chain amyloidosis involving myocardium.
This study was designed according to the 18F-florbetaben positron emission tomography imaging, which successfully demonstrated a significant reduction in the amount of amyloid in the heart when administered by merging thalidomide and dexamethasone in patients involving myocardium, and reported that this reaction leads to an improvement in cardiac function. Amyloid light-chain amyloidosis patients at age 19 or older with refractory or relapsed who participants should have never been exposed to lenalidomide within 5 years. Planned initial dosage of the current regimen are as follow; * Lenalidomide : D1\~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg. * Dexamethasone : D1\~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted. The investigator is working on a total of 30 patients, the primary endpoint of this study is objective response rate and secondary endpoints are cardiac/renal/hepatic function, 18F-florbetaben positron emission tomography imaging parameter, overall survival period, progression-free survival period, toxicity profile.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
As single arm study, patients will be treated as follows: * Lenalidomide : D1\~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg. * Dexamethasone : D1\~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted.
Seoul National University Hospital
Seoul, South Korea
Objective response rate (ORR)
ORR is defined as the percentage of subjects with evidence of a confirmed CR(complete response), VGPR(very good partial response) or PR(partial response)
Time frame: After completion of 12 cycles of treatment(each cycle is 28 days)
Change of the cardiac function
Change of the cardiac function will be observed with the NTproBNP levels.
Time frame: At Baseline and the end of each 1-12 cycles (baseline and 1-12 months)
Change of the renal function
Change of the renal function will be observed with the 24h urine protein levels.
Time frame: At Baseline and the end of each 1-12 cycles (baseline and 1-12 months)
Change of the hepatic function
Change of the hepatic function will be observed with the alkaline phophatase levels.
Time frame: At Baseline and the end of each 1-12 cycles (baseline and 1-12 months)
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