Subjects will be screened for eligibility and then, after signing an Informed Consent Form, the first peripheral blood will be obtained.~Periodical blood samples will be obtained from the participants. Relapse patients will have their retrospective blood samples analyzed to identify early signs of disease.~The first stage (discovery phase) will include at least 30 patients from each of the following groups: MM, pre-MM conditions (SMM and MGUS), HL, aggressive NHL (DLBCL, HGL, FL, and MZL transformed to large cell lymphoma), FL, MZL, de novo AML, secondary AML, MDS, and healthy subjects.~In the second stage, at least 250 patients with MM and 250 patients with NHL, and at least 100 patients with each of the remaining blood cancer conditions mentioned above will be tested. It is expected that the majority of these patients will be tested also during the disease follow-up.~The last stage consists of the screening of a larger group of subjects with a high risk of blood cancer. This stage will include three populations: up to 1000 follow-up patients from each blood cancer: AML, lymphoma, and MM, up to 600 elderly patients (>65 years old) at risk of developing MM, and up to 400 first-degree relatives of patients (and in particular siblings). In order to allow a maximum follow-up period for at-risk subjects as part of the study, and to meet the recruitment goals, the screening, and enrollment can begin in the first stage of the trial.~In all stages, the age and sex-matched subgroups will be considered and matched.~In addition, as part of the discovery stage, bone marrow samples will be obtained at Tel-Aviv Sourasky Medical Center (TASMC) from up to 50 MM patients and up to 50 AML patients that undergo bone marrow aspiration as part of the standard care procedure. Additionally, up to 50 bone marrow samples will be taken from healthy volunteers that will undergo hip or knee replacement surgery. Blood samples will be collected from the same participants.~During the follow-up period, demographic and baseline parameters including sex, age, race, height and weight, medical history, details of initial diagnosis and treatment history, concomitant medications as well as adverse events (AEs) of special interest (see section 9.1), (serious) AEs related to study procedures, treatment for the disease and disease response will be collected (as applicable).
This is a multicenter, open-label, non-interventional controlled study to identify and characterize the epigenetic signatures for a set of hematological malignancies: Multiple myeloma (MM), pre-MM conditions [smoldering MM (SMM) and monoclonal gammopathy of undetermined significance (MGUS)], Hodgkin lymphoma (HL), non-Hodgkin aggressive lymphoma NHL [diffuse large B cell lymphoma (DLBCL), high-grade lymphoma (HGL), follicular lymphoma (FL) and marginal zone lymphoma (MZL) transformed to large cell lymphoma], FL, MZL, de novo acute myeloid leukemia (AML), secondary AML, myelodysplastic syndrome (MDS) and healthy subjects.