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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Carita
        • 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
        • Fundação 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Myeloma Network B.V.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2037

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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