Clinical Trial: Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial

Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL

Official Title: Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)

Brief Summary: The purpose of this study is to determine the event-free survival (EFS) after 3-6 versus 18 cycles of daratumumab maintenance following 6 cycles induction of daratumumab-CyBorD in newly diagnosed AL amyloidosis.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: The point estimate for the hazard ratio and corresponding one-sided 85% confidence interval will be generated with a stratified Cox regression (using the trial stratification factors) that has treatment arm as an exploratory variable.

Original Primary Outcome: The point estimate for the hazard ratio and corresponding one-sided 85% confidence interval will be generated with a stratified Cox regression (using the trial stratification factors) that has treatment arm as an exploratory variable.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: June 02, 2023
Date Started: 2023-06
Date Completion: {'date': '2023-06', 'type': 'ESTIMATED'}
Last Updated: 2023-06-02
Last Verified: 2023-06