AL Amyloidosis and Anti-CD38-Daratunuma… | Clinical Trial

Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Giovanni Bosco Hospital

Turin, Piedmont, 10154, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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".

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Acronym: AL38

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Aug 26, 2024
Registry last updated: Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed