Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2022-12-21
2037-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
storage of biological samples
collect and store biological samples
Interventions
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storage of biological samples
collect and store biological samples
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
European Myeloma Network B.V.
NETWORK
Responsible Party
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Locations
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Alfred Hospital
Melbourne, , Australia
KUK Linz
Linz, , Austria
Medical University Vienna
Vienna, , Austria
Department of Haematology UZ Leuven Gasthuisberg
Leuven, , Belgium
Nemocnice Havířov
Havířov, , Czechia
Nemocnice Nový Jičín
Nový Jičín, , Czechia
Fakultní nemocnice
Olomouc, , Czechia
Slezská nemocnice
Opava, , Czechia
Fakutni nemocnice Ostrava
Ostrava, , Czechia
Nemocnice Pelhrimov
Pelhřimov, , Czechia
Všeobecná Fakultní nemocnice v Praz
Prague, , Czechia
Regional General Hospital Alexandra Dept of Clinical Therapeutics
Athens, , Greece
Theagenion Cancer Hospital
Thessaloniki, , Greece
Beaumont Hospital, Dublin, Hematology Department
Galway, , Ireland
A.O. 'SS. Antonio e Biagio'
Alessandria, , Italy
AOU Ospedali Riuniti di Ancona
Ancona, , Italy
Bari-A.O.U. Consorziale Policlinico - Medicina Interna
Bari, , Italy
Policlinico S Orsola Malpighi
Bologna, , Italy
A.O.Spedali Civili di Brescia
Brescia, , Italy
A.S.U.R. Regione Marche
Civitanova Marche, , Italy
A.O.U. Careggi
Florence, , Italy
A.O.U. Policlinico S. Martino - Clinica Ematologica
Genova, , Italy
A.O.U. Policlinico S. Martino - Ematologia
Genova, , Italy
A.O. 'Cardinale G.Panico'
Lecce, , Italy
A.O. di Rilievo Nazionale A. Cardarelli
Napoli, , Italy
A.O.U. Maggiore della Carità
Novara, , Italy
Policlinico S. Matteo Fondazione IRCCS - Pavia
Pavia, , Italy
A.O. San Camillo-Forlanini
Roma, , Italy
Ospedale S. Eugenio
Roma, , Italy
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
A.O. S. Maria
Terni, , Italy
A.O.U. Città della Salute e della Scienza di Torino - PO Molinette
Torino, , Italy
Azienda Ospedaliera Universitaria di Udine
Udine, , Italy
ULSS8 Berica Ospedale S.Bortolo
Vicenza, , Italy
CHUC
Coimbra, , Portugal
Fundação Champalimaud
Lisbon, , Portugal
Chsj - Hosp. Sao Joao
Porto, , Portugal
IPOP Porto
Porto, , Portugal
Clinic of Hematology, University Clinical Center of Serbia
Belgrade, , Serbia
CHUV
Lausanne, , Switzerland
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Schmitt
Role: primary
Krauth
Role: primary
Mikula
Role: primary
Wrobel
Role: primary
Minařík
Role: primary
Stejskal
Role: primary
Hajek
Role: primary
Kessler
Role: primary
Pavlicek
Role: primary
Terpos
Role: primary
Katodrytou
Role: primary
Monaco
Role: primary
Offidani
Role: primary
Zamagni
Role: primary
Belotti
Role: primary
Antonioli
Role: primary
Aquino
Role: primary
Palmieri
Role: primary
Casaluci
Role: primary
Mangiacavalli
Role: primary
Falcone
Role: primary
Liberati
Role: primary
D'Agostino
Role: primary
Francesca Patriarca
Role: primary
Bila
Role: primary
Other Identifiers
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EMN36
Identifier Type: -
Identifier Source: org_study_id
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