AL Amyloidosis and Anti-CD38-Daratunumab
Not Applicable
Completed
- Conditions
- Amyloidosis
- Interventions
- Drug: Anti-CD38 Monoclonal Antibody
- Registration Number
- NCT06571864
- Lead Sponsor
- University of Turin, Italy
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Patients affected by AL amyloidosis
- Patients who were ineligible for high dose therapy and bone marrow transplantation due to age and/or frailty score.
Exclusion criteria:
- Diagnosis of AL amyloidosis not biospy proven
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description anti-CD38 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)
- Primary Outcome Measures
Name Time Method organ responses were defined according to the updated International Society of Amyloidosis criteria "through study completion, an average of 1 year".
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
San Giovanni Bosco Hospital
🇮🇹Turin, Piedmont, Italy