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AL Amyloidosis and anti-CD38
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-CD38 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD38 Monoclonal Antibody | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| organ responses were defined according to the updated International Society of Amyloidosis criteria | "through study completion, an average of 1 year". |
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Inclusion Criteria:
Exclusion criteria:
- Diagnosis of AL amyloidosis not biospy proven
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| Name | Affiliation | Role |
|---|---|---|
| Dario Roccatello | ASL Città di Torino, Torino, IT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Giovanni Bosco Hospital | Turin | Piedmont | 10154 | Italy |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
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