NCT06571864

Brief Summary

AL Amyloidosis and anti-CD38

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 20, 2024

Last Update Submit

August 22, 2024

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

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

    "through study completion, an average of 1 year".

Study Arms (1)

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)

Drug: Anti-CD38 Monoclonal Antibody

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)

anti-CD38

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients affected by AL amyloidosis
  • Patients who were ineligible for high dose therapy and bone marrow transplantation due to age and/or frailty score.

You may not qualify if:

  • \- Diagnosis of AL amyloidosis not biospy proven

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni Bosco Hospital

Turin, Piedmont, 10154, Italy

Location

MeSH Terms

Conditions

Amyloidosis

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dario Roccatello

    ASL Città di Torino, Torino, IT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 26, 2024

Study Start

January 2, 2022

Primary Completion

January 2, 2024

Study Completion

February 2, 2024

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)