Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD (TELO - DMRD)

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

The purpose :

Detect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Diagnostic test: Standard of care

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Rayan Kaedbey, MD FRCPC; Phone Number: 514-340-8222; Email: rayan.kaedbey.med@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
      • Contact: Rayan Kaedbey, MD; Phone Number: 28799 514 340 8222; Email: rayan.kaedbey@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participant having confirmed Multiple Myeloma diagnosis will be enrolled in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRD level group; Participants will be defined as diagnosed with multiple myeloma	Diagnostic test: Standard of care; Participants will not receive any intervention in this study. Participants will receive standard of care therapy

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

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Investigators: Principal Investigator: Rayan Kaedbey, Sir Mortimer B. Davis - Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: Telo Genomics Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No