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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06205953
Other study ID # AC-021-EU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date June 1, 2026

Study information

Verified date April 2024
Source IRCCS Policlinico S. Matteo
Contact Giovanni Palladini
Phone +390382502994
Email segreteria.amiloidosi@smatteo.pv.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.


Description:

In the frame of the EUREKA Consortium, a patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers across Europe or at their satellite sites will be created, in association with a cross-border biorepository and sample sharing network for the study of both disease-causing light chains and plasma cells with advanced molecular technologies. A dedicated site will support the Consortium with big data analysis and artificial intelligence applied to health. The aims are: 1) Defining the impact of advanced molecular technologies to promote early diagnosis and guide therapeutic choices; 2) describing the natural history of the disease in a representative cohort of AL patients in the contemporary era of effective anti-plasma cell therapies; 3) investigating and refining novel advanced technologies to detect with high sensitivity residual disease-causing plasma cells/light chains in patients achieving a complete hematologic response to therapy (minimal residual disease, MRD).


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date June 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - diagnosis of systemic AL amyloidosis; - treatment-naïve; - age =18 years; - ability to understand and willingness to sign an informed consent; - planned follow-up at participating center. Exclusion Criteria: - non-AL amyloidosis; - previous treatment for AL amyloidosis.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Medical Department, Amyloidosis Center, University Hospital, Im Neuenheimer Feld 672 Heidelberg
Italy Fondazione IRCCS Policlinico San Matteo, Pavia, Viale Golgi 19, 27100 Pavia
Netherlands UMC Utrecht, dept Hematology, Amyloid Expertise Center, Utrecht, Heidelberglaan Utrecht
Spain Instituto de Investigación Sanitaria de Navarra (IdiSNA) C. de Irunlarrea, 3, 31008 Pamplona, Navarra Pamplona
Switzerland University of Applied Sciences and Arts Northwestern Switzerland, Institute of Medical Engineering and Medical Informatics Muttenz

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality at 24 months by stage Mortality at 24 months by stage will be evaluated 24 months from diagnosis
Secondary Rate of hematologic relapse in Complete Response patients at 2 years by MRD status Rate of hematologic relapse in Complete Response patients at 2 years by MRD status will be evaluated 2 years from diagnosis
See also
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Completed NCT01570387 - A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis Phase 1/Phase 2
Terminated NCT03154047 - Study in Subjects With Light Chain (AL) Amyloidosis Phase 2
Completed NCT03236792 - Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis Phase 1/Phase 2
Recruiting NCT04392960 - Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis N/A
Recruiting NCT05898646 - Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial Phase 2