European Myeloma Network (EMN) Sample Project

Multiple Myeloma Clinical Trial

— EMN36  

Official title:

EMN Prospective Sample Collection Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237803
• Other study ID #: EMN36
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Leukemia, Plasma Cell
• MGUS
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Leukemia
• Smoldering Multiple Myeloma

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	Všeobecná 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