AL Amyloidosis and Anti-CD38-Daratunumab

University of Turin, Italy14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyloidosis

Interventions

Anti-CD38 Monoclonal AntibodyDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

San Giovanni Bosco Hospital

Turin, Piedmont, Italy

Outcomes

Primary Outcomes

organ responses were defined according to the updated International Society of Amyloidosis criteria

Time frame: "through study completion, an average of 1 year".

Data from ClinicalTrials.gov

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