Multiple MyelomaEMN36NCT06237803
European Myeloma Network (EMN) Sample Project
An observational study of Multiple Myeloma and Smoldering Multiple Myeloma, run by European Myeloma Network B.V. at 41 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Smoldering Multiple Myeloma, Plasma Cell Leukemia
- What is being tested?
- storage of biological samples
- How many people
- 6,000 participants
- Where
- 41 sitesin 10 countries
- Study dates
- 21 Dec 2022to Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
41 sites in 10 countries
Italy20 sites, 20 recruiting
- Recruiting
A.O. 'SS. Antonio e Biagio'
Alessandria
Monaco
- Recruiting
AOU Ospedali Riuniti di Ancona
Ancona
Offidani
- Recruiting
Bari-A.O.U. Consorziale Policlinico - Medicina Interna
Bari
Ria
- Recruiting
Policlinico S Orsola Malpighi
Bologna
Zamagni
- Recruiting
A.O.Spedali Civili di Brescia
Brescia
Belotti
- Recruiting
A.S.U.R. Regione Marche
Civitanova Marche
Mirabile
- Recruiting
A.O.U. Careggi
Florence
Antonioli
- Recruiting
A.O.U. Policlinico S. Martino - Clinica Ematologica
Genova
Cea
- Recruiting
A.O.U. Policlinico S. Martino - Ematologia
Genova
Aquino
Aquino
- Recruiting
A.O. 'Cardinale G.Panico'
Lecce
Mele
- Recruiting
A.O. di Rilievo Nazionale A. Cardarelli
Naples
Palmieri
- Recruiting
A.O.U. Maggiore della Carità
Novara
Casaluci
- Recruiting
Policlinico S. Matteo Fondazione IRCCS - Pavia
Pavia
Mangiacavalli
- Recruiting
A.O. San Camillo-Forlanini
Roma
Garzia
- Recruiting
Ospedale S. Eugenio
Roma
Ferraro
- Recruiting
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Falcone
- Recruiting
A.O. S. Maria
Terni
Liberati
Liso
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino - PO Molinette
Torino
D'Agostino
- Recruiting
Azienda Ospedaliera Universitaria di Udine
Udine
Francesca Patriarca
- Recruiting
ULSS8 Berica Ospedale S.Bortolo
Vicenza
Barillà
Czechia7 sites, 7 recruiting
- Recruiting
Nemocnice Havířov
Havířov
Mikula
- Recruiting
Nemocnice Nový Jičín
Nový Jičín
Wrobel
- Recruiting
Fakultní nemocnice
Olomouc
Minařík
- Recruiting
Slezská nemocnice
Opava
Stejskal
- Recruiting
Fakutni nemocnice Ostrava
Ostrava
Hajek
- Recruiting
Nemocnice Pelhrimov
Pelhřimov
Kessler
- Recruiting
Všeobecná Fakultní nemocnice v Praz
Prague
Pavlicek
Portugal4 sites, 4 recruiting
- Recruiting
CHUC
Coimbra
Roque
- Recruiting
Fundação Champalimaud
Lisbon
João
- Recruiting
Chsj - Hosp. Sao Joao
Porto
Bergantim
- Recruiting
IPOP Porto
Porto
Barreto
Austria2 sites, 2 recruiting
- Recruiting
KUK Linz
Linz
Schmitt
- Recruiting
Medical University Vienna
Vienna
Krauth
Greece2 sites, 2 recruiting
- Recruiting
Regional General Hospital Alexandra Dept of Clinical Therapeutics
Athens
Terpos
- Recruiting
Theagenion Cancer Hospital
Thessaloniki
Katodrytou
Switzerland2 sites, 2 recruiting
- Recruiting
CHUV
Lausanne
Auner
- Recruiting
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen
Driessen
Belgium1 site, 1 recruiting
- Recruiting
Department of Haematology UZ Leuven Gasthuisberg
Leuven
Delforge
Ireland1 site, 1 recruiting
- Recruiting
Beaumont Hospital, Dublin, Hematology Department
Galway
Krawczyk
Serbia1 site, 1 recruiting
- Recruiting
Clinic of Hematology, University Clinical Center of Serbia
Belgrade
Bila
About this study
Official title: 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
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Myeloma, MGUS
- Being tested
- storage of biological samples
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma, Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
storage of biological samplesOther
collect and store biological samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: storage of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biobank
Collect biological samples for research studies related to improving medicine and care to the patient
Measured: up to 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start21 Dec 2022
- Primary completionDec 2037 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Myeloma Network B.V.
- Sponsor type
- Research network
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237803
- Sponsor's protocol ID
- EMN36
- Acronym
- EMN36
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMN Prospective Sample Collection Project
- ClinicalTrials.gov ID
- NCT06237803
- Acronym / sponsor ID
- EMN36 / EMN36
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Myeloma, MGUS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- European Myeloma Network B.V.Research network
- Collaborators
- Janssen, LP
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- Dec 2037 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with MGUS, SMM, MM, PCL | – | Other: storage of biological samplesSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| storage of biological samplescollect and store biological samples | Other | Subjects with MGUS, SMM, MM, PCL |
Primary outcome
Biobank
Time frame: up to 30 years
Collect biological samples for research studies related to improving medicine and care to the patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
41 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Smoldering Multiple Myeloma, run by European Myeloma Network B.V. at 41 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Italy, Czechia, Portugal, Austria, Greece and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Del Pietro (+31 10702687065, chiara.delpietro@emn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biobank (time frame: up to 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.