European Myeloma Network (EMN) Sample Project (EMN36)

European Myeloma Network B.V.

Status: Enrolling

Conditions: Plasma Cell Leukemia; Extramedullary Myeloma; Multiple Myeloma; MGUS; Smoldering Multiple Myeloma

Treatments: Other: storage of biological samples

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT06237803

EMN36

Details and patient eligibility

About

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

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

6,000 participants in 1 patient group

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.

Treatment:

Other: storage of biological samples