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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06237803
Other study ID # EMN36
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2022
Est. completion date December 2037

Study information

Verified date February 2024
Source Stichting European Myeloma Network
Contact Antonella Balsamo
Phone +31 107033123
Email antonella.balsamo@emn.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples. This study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date December 2037
Est. primary completion date December 2037
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+/- EMD), plasma cell leukemia (PCL) (+/- EMD) - Subjects are = 18 years old. - Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures. 1. Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and 2. subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements. Exclusion Criteria: - Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care). - Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events. - Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule.

Study Design


Intervention

Other:
storage of biological samples
collect and store biological samples

Locations

Country Name City State
Austria KUK Linz Linz
Austria Ordensklinikum Linz Linz
Austria Medical University Vienna Wien
Czechia Nemocnice Havírov Havírov
Czechia Nemocnice Nový Jicín Nový Jicín
Czechia Fakultní nemocnice Olomouc
Czechia Slezská nemocnice Opava
Czechia Fakutni nemocnice Ostrava Ostrava
Czechia Nemocnice Pelhrimov Pelhrimov
Czechia VÅ¡eobecná Fakultní nemocnice v Praz Praha
Greece Regional General Hospital Alexandra Dept of Clinical Therapeutics Athens
Greece Theagenion Cancer Hospital Thessaloníki
Italy A.O. 'SS. Antonio e Biagio' Alessandria
Italy AOU Ospedali Riuniti di Ancona Ancona
Italy Policlinico S Orsola Malpighi Bologna
Italy A.O.Spedali Civili di Brescia Brescia
Italy Ospedale Oncologico 'A. Businco' Cagliari
Italy A.O.U. Careggi Firenze
Italy A.O.U. Policlinico S. Martino - Ematologia Genova
Italy A.O.U. Policlinico 'G. Martino' Messina
Italy A.O. di Rilievo Nazionale A. Cardarelli Napoli
Italy A.O.U. Maggiore della Carità Novara
Italy A.O. di Padova Padova
Italy Policlinico S. Matteo Fondazione IRCCS - Pavia Pavia
Italy Policlinico Umberto I - Università 'Sapienza' Roma
Italy I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy A.O. S. Maria Terni
Italy A.O.U. Città della Salute e della Scienza di Torino-Ematologia U Torino
Italy Azienda Ospedaliera Universitaria di Udine Udine
Serbia Clinic of Hematology, University Clinical Center of Serbia Belgrad

Sponsors (2)

Lead Sponsor Collaborator
Stichting European Myeloma Network Janssen, LP

Countries where clinical trial is conducted

Austria,  Czechia,  Greece,  Italy,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biobank Collect biological samples for research studies related to improving medicine and care to the patient up to 30 years
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