NCT04298372

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of Lenalidomide

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Amyloidosis Cardiac

Interventions

Type	Name	Description
DRUG	Lenalidomide 25mg	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.

Timeline

• Start date: 2019-02-20
• Primary completion: 2021-11-25
• Completion: 2021-11-25
• First posted: 2020-03-06
• Last updated: 2024-04-17

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study