Clinical trial · Observational
European Myeloma Network (EMN) Sample Project
EMN Prospective Sample Collection Project
NCT06237803CI-TRIAL-00098262EMN36recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extramedullary Myeloma | — | UNRESOLVED | — |
| MGUS | Monoclonal Gammopathy of Undetermined Significance | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Plasma Cell Leukemia | Plasma Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| Smoldering Multiple Myeloma | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| storage of biological samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects with MGUS, SMM, MM, PCL
- description
- 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.
- interventionNames
- Other: storage of biological samples
Primary outcomes (1)
- measure
- Biobank
- timeFrame
- up to 30 years
- description
- Collect biological samples for research studies related to improving medicine and care to the patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.