European Myeloma Network (EMN) Sample Project
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Myeloma Network B.V.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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 design
Treatments tested in this trial
- storage of biological samples
Treatment groups
6,000 Participants
are divided into 1 treatment groupSponsors and collaborators
European Myeloma Network B.V.
Lead sponsor
Janssen, LP
Collaborator
Source ClinicalTrials.gov