CompletedPhase 3

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium

South Korea2 participantsStarted 2019-02-20

Plain-language summary

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.

Who can participate

Age range19 Years – 99 Years

SexALL

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Inclusion criteria

✓. Echocardiography : mean wall thickness \> 12mm, and no other cardiac cause
✓. 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 gadolinium enhancement of the LV myocardium.
✓. N-terminal prohormone of brain natriuretic peptide : \> 332ng/l in the absence pf renal failure
✓. Serum creatinine ≤ 3.0mg/dl or Creatinine Clearance ≥ 50ml/minute (Cockcroft-Gault)
✓. Absolute neutrophil count ≥ 1000/ul
✓. Platelet ≥ 75,000/ul
✓. Hemoglobin ≥ 8.0mg/dl
✓. Bilirubin \< 2 times or Alkaline phosphate \< 4 times upper limit of normal

What they're measuring

Objective response rate (ORR)

Timeframe: After completion of 12 cycles of treatment(each cycle is 28 days)

Trial details

NCT IDNCT04298372

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-25

View on ClinicalTrials.gov More Amyloidosis Cardiac trials