Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD

Study Overview
=================
Brief Summary
-----------------
The purpose : Detect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.

Official Title
-----------------
Detect and Profile Multiple Myeloma Measurable Residual Disease (MRD )Prognostics for Monitoring Post-transplant Multiple Myeloma (MM) Patients Receiving Maintenance Therapy.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Diagnostic Test: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed MM diagnosis Transplant eligible patients in a first remission Known MRD level detected by ClonoSeq (other IMWG recognized methodologies can be also employed) Availability of deidentified patient's demographic and clinical follow up data Receiving standard of care treatment Able to provide informed consent Exclusion Criteria: Failure to meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRD level group<br>Participants will be defined as diagnosed with multiple myeloma | Diagnostic Test: Standard of care<br>* Participants will not receive any intervention in this study. Participants will receive standard of care therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the sensitivity of Telo Genomics assay (measurement tool) to detect MRD (measurement expressed in the number of plasma cells per 100000 cells) and establish the clinical utility of TELO - DMRD for MRD enumeration | Assess the possibility to perform TELO-DMRD on bone marrow aspirate samples vs peripheral blood Validate TELO-DMRD results with ClonoSeq, as an IMWG recognized MRD assessment method (other IMWG recognized methodologies can be also employed) | Approximately 5 years | 
| To assess the utility of TeloView® technology genomic profiling (measurement tool) to stratify post-transplant MM patients into relapse risk groups (dichotomous measure of high or low) by analyzing the residual MRD plasma cells | o A longitudinal study including transplant eligible patients. Patients to be followed for 6 time points over 24 months at: At point of diagnosis (marrow aspirate & peripheral blood), 4m post induction (peripheral blood), 3m Post-transplant (peripheral blood), at 12m Post-transplant (peripheral blood), 18m Post-transplant (peripheral blood) & 24m Post-transplant (peripheral blood), and at point of relapse for patients who will relapse during the follow up time (marrow aspirate & peripheral blood). Of note, an additional marrow aspirate may be performed if the patient agrees at the time they attain a complete remission, to confirm this status | Approximately 5 years |