European Myeloma Network (EMN) Sample Project

Recruiting

• Conditions: Multiple Myeloma; Plasma Cell Leukemia; Extramedullary Myeloma; MGUS; Smoldering Multiple Myeloma
• Interventions: Other: storage of biological samples

• Registration Number: NCT06237803
• Lead Sponsor: European Myeloma Network B.V.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-21
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Primary Completion: 2037-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with MGUS, SMM, MM, PCL	storage of biological samples	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.

Primary Outcome Measures

Name	Time	Method
Biobank	up to 30 years	Collect biological samples for research studies related to improving medicine and care to the patient

Trial Locations

Locations (30)

Fakutni nemocnice Ostrava; 🇨🇿 Ostrava, Czechia

Nemocnice Pelhrimov; 🇨🇿 Pelhřimov, Czechia

Všeobecná Fakultní nemocnice v Praz; 🇨🇿 Praha, Czechia

Nemocnice Havířov; 🇨🇿 Havířov, Czechia

Ordensklinikum Linz; 🇦🇹 Linz, Austria

Ospedale Oncologico 'A. Businco'; 🇮🇹 Cagliari, Italy

A.O. di Rilievo Nazionale A. Cardarelli; 🇮🇹 Napoli, Italy

A.O. S. Maria; 🇮🇹 Terni, Italy

KUK Linz; 🇦🇹 Linz, Austria

Medical University Vienna; 🇦🇹 Wien, Austria

Regional General Hospital Alexandra Dept of Clinical Therapeutics; 🇬🇷 Athens, Greece

A.O. 'SS. Antonio e Biagio'; 🇮🇹 Alessandria, Italy

AOU Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Italy

A.O.U. Policlinico S. Martino - Ematologia; 🇮🇹 Genova, Italy

A.O.U. Maggiore della Carità; 🇮🇹 Novara, Italy

A.O. di Padova; 🇮🇹 Padova, Italy

Policlinico S. Matteo Fondazione IRCCS - Pavia; 🇮🇹 Pavia, Italy

A.O.U. Città della Salute e della Scienza di Torino-Ematologia U; 🇮🇹 Torino, Italy

Slezská nemocnice; 🇨🇿 Opava, Czechia

A.O.U. Careggi; 🇮🇹 Firenze, Italy

Nemocnice Nový Jičín; 🇨🇿 Nový Jičín, Czechia

Policlinico S Orsola Malpighi; 🇮🇹 Bologna, Italy

A.O.Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

Fakultní nemocnice; 🇨🇿 Olomouc, Czechia

Theagenion Cancer Hospital; 🇬🇷 Thessaloníki, Greece

A.O.U. Policlinico 'G. Martino'; 🇮🇹 Messina, Italy

Azienda Ospedaliera Universitaria di Udine; 🇮🇹 Udine, Italy

Clinic of Hematology, University Clinical Center of Serbia; 🇷🇸 Belgrad, Serbia

Policlinico Umberto I - Università 'Sapienza'; 🇮🇹 Roma, Italy