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Recruiting NCT06237803

European Myeloma Network (EMN) Sample Project

— Observational Multiple Myeloma Smoldering Multiple Myeloma Plasma Cell Leukemia Extramedullary Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: storage of biological samples.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Smoldering Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Austria, Belgium, Czechia, Greece +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

EMN Prospective Sample Collection Project

Overview

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

Interventions

  • Other storage of biological samples
    collect and store biological samples

Primary outcome measures

  • Biobank [Time frame: up to 30 years]

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.
  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 20 centers
  • A.O. 'SS. Antonio e Biagio' — Alessandria
  • AOU Ospedali Riuniti di Ancona — Ancona
  • Bari-A.O.U. Consorziale Policlinico - Medicina Interna — Bari
  • Policlinico S Orsola Malpighi — Bologna
  • A.O.Spedali Civili di Brescia — Brescia
  • A.S.U.R. Regione Marche — Civitanova Marche
  • A.O.U. Careggi — Florence
  • A.O.U. Policlinico S. Martino - Clinica Ematologica — Genova
  • … and 12 more centers
Czechia · 7 centers
  • Nemocnice Havířov — Havířov
  • Nemocnice Nový Jičín — Nový Jičín
  • Fakultní nemocnice — Olomouc
  • Slezská nemocnice — Opava
  • Fakutni nemocnice Ostrava — Ostrava
  • Nemocnice Pelhrimov — Pelhřimov
  • Všeobecná Fakultní nemocnice v Praz — Prague
Portugal · 4 centers
  • CHUC — Coimbra
  • Fundação Champalimaud — Lisbon
  • Chsj - Hosp. Sao Joao — Porto
  • IPOP Porto — Porto
Austria · 2 centers
  • KUK Linz — Linz
  • Medical University Vienna — Vienna
Greece · 2 centers
  • Regional General Hospital Alexandra Dept of Clinical Therapeutics — Athens
  • Theagenion Cancer Hospital — Thessaloniki
Switzerland · 2 centers
  • CHUV — Lausanne
  • HOCH Health Ostschweiz Kantonsspital St.Gallen — Sankt Gallen
Australia · 1 center
  • Alfred Hospital — Melbourne
Belgium · 1 center
  • Department of Haematology UZ Leuven Gasthuisberg — Leuven
Ireland · 1 center
  • Beaumont Hospital, Dublin, Hematology Department — Galway
Serbia · 1 center
  • Clinic of Hematology, University Clinical Center of Serbia — Belgrade

Identifiers

NCT: NCT06237803 · EMN36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗