EMN Prospective Sample Collection Project

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

‣ 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

⁃ subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.

Locations
Other Locations
Austria
KUK Linz
RECRUITING
Linz
Ordensklinikum Linz
RECRUITING
Linz
Medical University Vienna
RECRUITING
Vienna
Greece
Regional General Hospital Alexandra Dept of Clinical Therapeutics
RECRUITING
Athens
Theagenion Cancer Hospital
RECRUITING
Thessaloniki
Italy
A.O. 'SS. Antonio e Biagio'
RECRUITING
Alessandria
AOU Ospedali Riuniti di Ancona
RECRUITING
Ancona
Policlinico S Orsola Malpighi
RECRUITING
Bologna
A.O.Spedali Civili di Brescia
RECRUITING
Brescia
Ospedale Oncologico 'A. Businco'
RECRUITING
Cagliari
A.O.U. Careggi
RECRUITING
Florence
A.O.U. Policlinico S. Martino - Ematologia
RECRUITING
Genova
A.O.U. Policlinico 'G. Martino'
RECRUITING
Messina
A.O. di Rilievo Nazionale A. Cardarelli
RECRUITING
Napoli
A.O.U. Maggiore della Carità
RECRUITING
Novara
A.O. di Padova
RECRUITING
Padua
Policlinico S. Matteo Fondazione IRCCS - Pavia
RECRUITING
Pavia
Policlinico Umberto I - Università 'Sapienza'
RECRUITING
Roma
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
A.O. S. Maria
RECRUITING
Terni
A.O.U. Città della Salute e della Scienza di Torino-Ematologia U
RECRUITING
Torino
Azienda Ospedaliera Universitaria di Udine
RECRUITING
Udine
Serbia
Clinic of Hematology, University Clinical Center of Serbia
RECRUITING
Belgrade
Contact Information
Primary
Antonella Balsamo
antonella.balsamo@emn.org
+31 107033123
Time Frame
Start Date: 2022-12-21
Estimated Completion Date: 2037-12
Participants
Target number of participants: 6000
Treatments
Subjects with MGUS, SMM, MM, PCL
Subjects with Monoclonal Gammopathy of Undetermined Significance (MGUS), smouldering Multiple Myeloma (SMM), Multiple Myeloma (MM), Plasma Cell Leukemia (PCL)~Timepoints and samples to be collected are the following:~* bone marrow aspirate, bone marrow biopsy, EMD biopsy, peripheral blood and serum at baseline;~* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum pre-maintenance in TE patients or after 1 year of therapy in Non-Transplant-Eligible (NTE) patients;~* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum during maintenance therapy and only if performed as SOC;~* bone marrow aspirate, bone marrow biopsy, EMD biopsy peripheral blood and serum at 1st and later PD.
Sponsors
Leads: European Myeloma Network B.V.
Collaborators: Janssen, LP

This content was sourced from clinicaltrials.gov