Extramedullary Myeloma, MGUS, Multiple Myeloma, Plasma Cell Leukemia, Smoldering Multiple Myeloma
Conditions
Brief 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
Interventions
OTHERstorage of biological samples
collect and store biological samples
Sponsors
Janssen, LP
European Myeloma Network B.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biobank | up to 30 years | Collect biological samples for research studies related to improving medicine and care to the patient |
Countries
Australia, Austria, Belgium, Czechia, Greece, Ireland, Italy, Portugal, Serbia, Switzerland
Contacts
Primary ContactChiara Del Pietro
Outcome results
None listed