Collection and analysis of biological samples from patients with multiple myeloma and related conditions
EMN Prospective Sample Collection Project
This study is collecting and storing blood samples from patients with multiple myeloma and similar conditions to help researchers learn more about these diseases and improve treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Myeloma Network B.V. Research network |
| Locations | 41 sites (Melbourne and 40 other locations) |
| Trial ID | NCT06237803 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a common international infrastructure for the prospective collection, storage, and analysis of biological samples from patients diagnosed with multiple myeloma, smoldering multiple myeloma, plasma cell leukemia, and related conditions. It will gather standard clinical variables at baseline and during treatment to facilitate future research. The study involves multiple centers across Europe and focuses on creating a comprehensive biobank for better understanding and treatment of these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with MGUS, smoldering multiple myeloma, multiple myeloma, or plasma cell leukemia.
Not a fit: Patients who have previously received anti-myeloma therapy or have had serious adverse reactions to blood donation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of multiple myeloma and related conditions, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies focusing on biobanking and observational data collection in hematological malignancies have shown success, indicating the potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Melbourne and 40 other locations
- 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)
Study contacts
- Study coordinator: Chiara Del Pietro
- Email: chiara.delpietro@emn.org
- Phone: +31 10702687065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.