Clinical trial NCT06237803: European Myeloma Network (EMN) Sample Project
Official title: EMN Prospective Sample Collection Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Smoldering Multiple Myeloma
Plasma Cell Leukemia
Extramedullary Myeloma
MGUS
Lead sponsor: European Myeloma Network B.V.
Sponsor class: NETWORK
Collaborators: name: Janssen, LP
First posted: 2024-02-01
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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 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.

Primary outcomes:
measure: Biobank
timeFrame: up to 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: KUK Linz
city: Linz
country: Austria
facility: Ordensklinikum Linz
city: Wien
country: Austria
facility: Medical University Vienna
city: Havířov
country: Czechia
facility: Nemocnice Havířov
city: Nový Jičín
country: Czechia
facility: Nemocnice Nový Jičín
city: Olomouc
country: Czechia
facility: Fakultní nemocnice
city: Opava
country: Czechia
facility: Slezská nemocnice
city: Ostrava
country: Czechia
facility: Fakutni nemocnice Ostrava
city: Pelhřimov
country: Czechia
facility: Nemocnice Pelhrimov
city: Praha
country: Czechia
facility: Všeobecná Fakultní nemocnice v Praz
city: Athens
country: Greece
facility: Regional General Hospital Alexandra Dept of Clinical Therapeutics
city: Thessaloníki
country: Greece
facility: Theagenion Cancer Hospital
city: Alessandria
country: Italy
facility: A.O. 'SS. Antonio e Biagio'
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti di Ancona
city: Bologna
country: Italy
facility: Policlinico S Orsola Malpighi
city: Brescia
country: Italy
facility: A.O.Spedali Civili di Brescia
city: Cagliari
country: Italy
facility: Ospedale Oncologico 'A. Businco'
city: Firenze
country: Italy
facility: A.O.U. Careggi
city: Genova
country: Italy
facility: A.O.U. Policlinico S. Martino - Ematologia
city: Messina
country: Italy
facility: A.O.U. Policlinico 'G. Martino'
city: Napoli
country: Italy
facility: A.O. di Rilievo Nazionale A. Cardarelli
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
city: Padova
country: Italy
facility: A.O. di Padova
city: Pavia
country: Italy
facility: Policlinico S. Matteo Fondazione IRCCS - Pavia
city: Roma
country: Italy
facility: Policlinico Umberto I - Università 'Sapienza'
city: San Giovanni Rotondo
country: Italy
facility: I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
city: Terni
country: Italy
facility: A.O. S. Maria
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino-Ematologia U
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria di Udine
city: Belgrad
country: Serbia
facility: Clinic of Hematology, University Clinical Center of Serbia
Study officials:
References: