RecruitingNCT06237803
European Myeloma Network (EMN) Sample Project
EMN Prospective Sample Collection Project
Sponsor
European Myeloma Network B.V.
Enrollment
6,000 participants
Start Date
Dec 21, 2022
Study Type
OBSERVATIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria3
- 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.
Interventions
OTHERstorage of biological samples
collect and store biological samples
Locations(41)
View Full Details on ClinicalTrials.gov
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NCT06237803
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