Amyloidosis
Conditions
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
Interventions
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)
Sponsors
University of Turin, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| organ responses were defined according to the updated International Society of Amyloidosis criteria | through study completion, an average of 1 year. |
Countries
Italy
Outcome results
None listed