AL Amyloidosis and Anti-CD38-Daratunumab (AL38)

University of Turin

Status: Completed

Conditions: Amyloidosis

Treatments: Drug: Anti-CD38 Monoclonal Antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT06571864

DARA_01

Details and patient eligibility

About

AL Amyloidosis and anti-CD38

Full 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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

anti-CD38

Experimental group

Description:

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)

Treatment:

Drug: Anti-CD38 Monoclonal Antibody