Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital
About this trial
The purpose :
Detect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Failure to meet inclusion criteria
Trial population
Participant having confirmed Multiple Myeloma diagnosis will be enrolled in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard of care
Diagnostic testParticipants will not receive any intervention in this study. Participants will receive standard of care therapy
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: MRD level group1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Approximately 5 years2
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
Time frame
Approximately 5 yearsSponsors and contacts
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Source ClinicalTrials.gov