European Myeloma Network (EMN) Sample Project (EMN36)

December 2, 2025 updated by: European Myeloma Network B.V.

EMN Prospective Sample Collection Project

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Melbourne, Australia
        • Recruiting
        • Alfred Hospital
        • Principal Investigator:
          • Spencer
  • Austria
      • Linz, Austria
        • Recruiting
        • KUK Linz
        • Contact:
          • Schmitt
      • Vienna, Austria
        • Recruiting
        • Medical University Vienna
        • Contact:
          • Krauth
  • Belgium
      • Leuven, Belgium
        • Recruiting
        • Department of Haematology UZ Leuven Gasthuisberg
        • Principal Investigator:
          • Delforge
  • Czechia
      • Havířov, Czechia
        • Recruiting
        • Nemocnice Havířov
        • Contact:
          • Mikula
      • Nový Jičín, Czechia
        • Recruiting
        • Nemocnice Novy Jicin
        • Contact:
          • Wrobel
      • Olomouc, Czechia
        • Recruiting
        • Fakultní nemocnice
        • Contact:
          • Minarik
      • Opava, Czechia
        • Recruiting
        • Slezská nemocnice
        • Contact:
          • Stejskal
      • Ostrava, Czechia
        • Recruiting
        • Fakutni nemocnice Ostrava
        • Contact:
          • Hajek
      • Pelhřimov, Czechia
        • Recruiting
        • Nemocnice Pelhrimov
        • Contact:
          • Kessler
      • Prague, Czechia
        • Recruiting
        • Všeobecná Fakultní nemocnice v Praz
        • Contact:
          • Pavlicek
  • Greece
      • Athens, Greece
        • Recruiting
        • Regional General Hospital Alexandra Dept of Clinical Therapeutics
        • Contact:
          • Terpos
      • Thessaloniki, Greece
        • Recruiting
        • Theagenion Cancer Hospital
        • Contact:
          • Katodrytou
  • Ireland
      • Galway, Ireland
        • Recruiting
        • Beaumont Hospital, Dublin, Hematology Department
        • Principal Investigator:
          • Krawczyk
  • Italy
      • Alessandria, Italy
        • Recruiting
        • A.O. 'SS. Antonio e Biagio'
        • Contact:
          • Monaco
      • Ancona, Italy
        • Recruiting
        • AOU Ospedali Riuniti di Ancona
        • Contact:
          • Offidani
      • Bari, Italy
        • Recruiting
        • Bari-A.O.U. Consorziale Policlinico - Medicina Interna
        • Principal Investigator:
          • Ria
      • Bologna, Italy
        • Recruiting
        • Policlinico S Orsola Malpighi
        • Contact:
          • Zamagni
      • Brescia, Italy
        • Recruiting
        • A.O.Spedali Civili di Brescia
        • Contact:
          • Belotti
      • Civitanova Marche, Italy
        • Recruiting
        • A.S.U.R. Regione Marche
        • Principal Investigator:
          • Mirabile
      • Florence, Italy
        • Recruiting
        • A.O.U. Careggi
        • Contact:
          • Antonioli
      • Genova, Italy
        • Recruiting
        • A.O.U. Policlinico S. Martino - Ematologia
        • Contact:
          • Aquino
        • Principal Investigator:
          • Aquino
      • Genova, Italy
        • Recruiting
        • A.O.U. Policlinico S. Martino - Clinica Ematologica
        • Principal Investigator:
          • Cea
      • Lecce, Italy
        • Recruiting
        • A.O. 'Cardinale G.Panico'
        • Principal Investigator:
          • Mele
      • Napoli, Italy
        • Recruiting
        • A.O. di Rilievo Nazionale A. Cardarelli
        • Contact:
          • Palmieri
      • Novara, Italy
        • Recruiting
        • A.O.U. Maggiore della Carità
        • Contact:
          • Casaluci
      • Pavia, Italy
        • Recruiting
        • Policlinico S. Matteo Fondazione IRCCS - Pavia
        • Contact:
          • Mangiacavalli
      • Roma, Italy
        • Recruiting
        • Ospedale S. Eugenio
        • Principal Investigator:
          • Ferraro
      • Roma, Italy
        • Recruiting
        • A.O. San Camillo-Forlanini
        • Principal Investigator:
          • Garzia
      • San Giovanni Rotondo, Italy
        • Recruiting
        • I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
        • Contact:
          • Falcone
      • Terni, Italy
        • Recruiting
        • A.O. S. Maria
        • Contact:
          • Liberati
        • Principal Investigator:
          • Liso
      • Torino, Italy
        • Recruiting
        • A.O.U. Città della Salute e della Scienza di Torino - PO Molinette
        • Contact:
          • D'Agostino
      • Udine, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria di Udine
        • Contact:
          • Francesca Patriarca
      • Vicenza, Italy
        • Recruiting
        • ULSS8 Berica Ospedale S.Bortolo
        • Principal Investigator:
          • Barillà
  • Portugal
      • Coimbra, Portugal
        • Recruiting
        • CHUC
        • Principal Investigator:
          • Roque
      • Lisbon, Portugal
        • Recruiting
        • Fundacao Champalimaud
        • Principal Investigator:
          • João
      • Porto, Portugal
        • Recruiting
        • Chsj - Hosp. Sao Joao
        • Principal Investigator:
          • Bergantim
      • Porto, Portugal
        • Recruiting
        • IPOP Porto
        • Principal Investigator:
          • Barreto
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Clinic of Hematology, University Clinical Center of Serbia
        • Contact:
          • Bila
  • Switzerland
      • Lausanne, Switzerland
        • Recruiting
        • CHUV
        • Principal Investigator:
          • Auner
      • Sankt Gallen, Switzerland
        • Recruiting
        • HOCH Health Ostschweiz Kantonsspital St.Gallen
        • Principal Investigator:
          • Driessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: storage of biological samples
collect and store biological samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biobank
Time Frame: up to 30 years
Collect biological samples for research studies related to improving medicine and care to the patient
up to 30 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRD
Time Frame: up to 30 years
promoting MRD evaluation by NGS in upcoming clinical trials
up to 30 years
correlative research
Time Frame: up to 30 years
enabling correlative research with clinical trials; The study plans to collect, purify and store biological samples from participating patients appropriately and using common and standardised protocols in all centralised laboratories. The quality of the material collected and stored will be a measure of the ability to perform all the diagnostic tests required in the protocols.
up to 30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Myeloma Network B.V.

Collaborators

Janssen, LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2022

Primary Completion (Estimated)

December 1, 2037

Study Completion (Estimated)

December 1, 2037

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMN36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on storage of biological samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe