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