Trial Title:
European Myeloma Network (EMN) Sample Project
NCT ID:
NCT06237803
Condition:
Multiple Myeloma
Smoldering Multiple Myeloma
Plasma Cell Leukemia
Extramedullary Myeloma
MGUS
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Leukemia, Plasma Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
storage of biological samples
Description:
collect and store biological samples
Arm group label:
Subjects with MGUS, SMM, MM, PCL
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
Criteria for eligibility:
Study pop:
Patients in hospitals in countries that participate in European Myeloma Network (EMN)
trials; these patients may be included in upfront trials or in maintenance or relapse
trials later during their disease.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
KUK Linz
Address:
City:
Linz
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Schmitt
Facility:
Name:
Ordensklinikum Linz
Address:
City:
Linz
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Strassl
Facility:
Name:
Medical University Vienna
Address:
City:
Wien
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Krauth
Facility:
Name:
Nemocnice Havířov
Address:
City:
Havířov
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Mikula
Facility:
Name:
Nemocnice Nový Jičín
Address:
City:
Nový Jičín
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Wrobel
Facility:
Name:
Fakultní nemocnice
Address:
City:
Olomouc
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Minařík
Facility:
Name:
Slezská nemocnice
Address:
City:
Opava
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Stejskal
Facility:
Name:
Fakutni nemocnice Ostrava
Address:
City:
Ostrava
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Hajek
Facility:
Name:
Nemocnice Pelhrimov
Address:
City:
Pelhřimov
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Kessler
Facility:
Name:
Všeobecná Fakultní nemocnice v Praz
Address:
City:
Praha
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Pavlicek
Facility:
Name:
Regional General Hospital Alexandra Dept of Clinical Therapeutics
Address:
City:
Athens
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Terpos
Facility:
Name:
Theagenion Cancer Hospital
Address:
City:
Thessaloníki
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Katodrytou
Facility:
Name:
A.O. 'SS. Antonio e Biagio'
Address:
City:
Alessandria
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Monaco
Facility:
Name:
AOU Ospedali Riuniti di Ancona
Address:
City:
Ancona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Offidani
Facility:
Name:
Policlinico S Orsola Malpighi
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Cavo
Facility:
Name:
A.O.Spedali Civili di Brescia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Belotti
Facility:
Name:
Ospedale Oncologico 'A. Businco'
Address:
City:
Cagliari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Derudas
Facility:
Name:
A.O.U. Careggi
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonioli
Facility:
Name:
A.O.U. Policlinico S. Martino - Ematologia
Address:
City:
Genova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Aquino
Investigator:
Last name:
Aquino
Email:
Principal Investigator
Facility:
Name:
A.O.U. Policlinico 'G. Martino'
Address:
City:
Messina
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Allegra
Facility:
Name:
A.O. di Rilievo Nazionale A. Cardarelli
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Palmieri
Facility:
Name:
A.O.U. Maggiore della Carità
Address:
City:
Novara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Casaluci
Facility:
Name:
A.O. di Padova
Address:
City:
Padova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Zambello
Facility:
Name:
Policlinico S. Matteo Fondazione IRCCS - Pavia
Address:
City:
Pavia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mangiacavalli
Facility:
Name:
Policlinico Umberto I - Università 'Sapienza'
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Martelli
Facility:
Name:
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
Address:
City:
San Giovanni Rotondo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Falcone
Facility:
Name:
A.O. S. Maria
Address:
City:
Terni
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Liberati
Investigator:
Last name:
Liberati
Email:
Principal Investigator
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino-Ematologia U
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
D'Agostino
Facility:
Name:
Azienda Ospedaliera Universitaria di Udine
Address:
City:
Udine
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesca Patriarca
Facility:
Name:
Clinic of Hematology, University Clinical Center of Serbia
Address:
City:
Belgrad
Country:
Serbia
Status:
Recruiting
Contact:
Last name:
Bila
Start date:
December 21, 2022
Completion date:
December 2037
Lead sponsor:
Agency:
Stichting European Myeloma Network
Agency class:
Other
Collaborator:
Agency:
Janssen, LP
Agency class:
Industry
Source:
European Myeloma Network B.V.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06237803
