NCT06571864

AL Amyloidosis and Anti-CD38-Daratunumab

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AL Amyloidosis and anti-CD38

Detailed description

AL amyloidosis is a systemic disorder characterized by progressive multiorgan failure and premature death. While autologous stem cell transplantation (ASCT) is considered the standard therapy, eligibility is limited, and excludes a substantial proportion of patients. Recent guidelines recommend daratumumab-based regimens for these patients, but, particularly for cases with severe renal involvement, optimal treatment remains a challenge. This study explore the efficacy of daratumumab monotherapy in patients with histologically proven severe renal involvement who are ineligible for ASCT

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	Anti-CD38 Monoclonal Antibody	Anti-CD38 Monoclonal Antibody: Daratumumab is intravenously given at the dose of 16 mg/kg weekly for 8 weeks, then every two weeks for 8 more times, and lastly monthly until the 52nd week (8 more administrations)

Timeline

• Start date: 2022-01-02
• Primary completion: 2024-01-02
• Completion: 2024-02-02
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Italy