European Myeloma Network (EMN) Sample Project

NCT06237803 | Recruiting

• 1 other identifier: EMN36
• Study Type: observational
• Target: 6,000
• Locations: 9 countries
• Sites: 40

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

Conditions

Multiple Myeloma; MGUS; Plasma Cell Leukemia; Extramedullary Myeloma; Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Biobank

  Collect biological samples for research studies related to improving medicine and care to the patient

  up to 30 years

Study Arms (1)

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

Interventions

storage of biological samples OTHER

collect and store biological samples

Subjects with MGUS, SMM, MM, PCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen, LP: collaborator
• European Myeloma Network B.V.: lead

Study Sites (41)

Alfred Hospital

Melbourne, Australia

RECRUITING

KUK Linz

Linz, Austria

RECRUITING

Medical University Vienna

Vienna, Austria

RECRUITING

Department of Haematology UZ Leuven Gasthuisberg

Leuven, Belgium

RECRUITING

Nemocnice Havířov

Havířov, Czechia

RECRUITING

Nemocnice Nový Jičín

Nový Jičín, Czechia

RECRUITING

Fakultní nemocnice

Olomouc, Czechia

RECRUITING

Slezská nemocnice

Opava, Czechia

RECRUITING

Fakutni nemocnice Ostrava

Ostrava, Czechia

RECRUITING

Nemocnice Pelhrimov

Pelhřimov, Czechia

RECRUITING

Všeobecná Fakultní nemocnice v Praz

Prague, Czechia

RECRUITING

Regional General Hospital Alexandra Dept of Clinical Therapeutics

Athens, Greece

RECRUITING

Theagenion Cancer Hospital

Thessaloniki, Greece

RECRUITING

Beaumont Hospital, Dublin, Hematology Department

Galway, Ireland

RECRUITING

A.O. 'SS. Antonio e Biagio'

Alessandria, Italy

RECRUITING

AOU Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Bari-A.O.U. Consorziale Policlinico - Medicina Interna

Bari, Italy

RECRUITING

Policlinico S Orsola Malpighi

Bologna, Italy

RECRUITING

A.O.Spedali Civili di Brescia

Brescia, Italy

RECRUITING

A.S.U.R. Regione Marche

Civitanova Marche, Italy

RECRUITING

A.O.U. Careggi

Florence, Italy

RECRUITING

A.O.U. Policlinico S. Martino - Clinica Ematologica

Genova, Italy

RECRUITING

A.O.U. Policlinico S. Martino - Ematologia

Genova, Italy

RECRUITING

A.O. 'Cardinale G.Panico'

Lecce, Italy

RECRUITING

A.O. di Rilievo Nazionale A. Cardarelli

Naples, Italy

RECRUITING

A.O.U. Maggiore della Carità

Novara, Italy

RECRUITING

Policlinico S. Matteo Fondazione IRCCS - Pavia

Pavia, Italy

RECRUITING

A.O. San Camillo-Forlanini

Roma, Italy

RECRUITING

Ospedale S. Eugenio

Roma, Italy

RECRUITING

I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

RECRUITING

A.O. S. Maria

Terni, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza di Torino - PO Molinette

Torino, Italy

RECRUITING

Azienda Ospedaliera Universitaria di Udine

Udine, Italy

RECRUITING

ULSS8 Berica Ospedale S.Bortolo

Vicenza, Italy

RECRUITING

CHUC

Coimbra, Portugal

RECRUITING

Fundação Champalimaud

Lisbon, Portugal

RECRUITING

Chsj - Hosp. Sao Joao

Porto, Portugal

RECRUITING

IPOP Porto

Porto, Portugal

RECRUITING

Clinic of Hematology, University Clinical Center of Serbia

Belgrade, Serbia

RECRUITING

CHUV

Lausanne, Switzerland

RECRUITING

HOCH Health Ostschweiz Kantonsspital St.Gallen

Sankt Gallen, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* bone marrow aspirate, bone marrow biopsy, extramedullary disease (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 patients; * bone marrow aspirate, bone marrow biopsy, peripheral blood and serum during maintenance therapy and only if performed as standard of care (SOC); * bone marrow aspirate, bone marrow biopsy, EMD biopsy peripheral blood and serum at 1st and later progressive disease (PD).

MeSH Terms

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma; Leukemia, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia; Leukemia

Central Study Contacts

Chiara Del Pietro

CONTACT

+31 10702687065; chiara.delpietro@emn.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 1, 2024
• Study Start: December 21, 2022
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2037
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

PT (4); AU (2); IT (20); IE (1); BE (1); GR (2); CH (2); CZ (7); SE (1)