Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Diagnostic Test: Standard of care

• Registration Number: NCT05530096
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2024-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRD level group	Standard of care	Participants will be defined as diagnosed with multiple myeloma

Primary Outcome Measures

Name	Time	Method
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	Approximately 5 years	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)
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	Approximately 5 years	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

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada