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NCT Number: NCT05530096

Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD

The purpose :

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location status: Recruiting

Location contact

Rayan Kaedbey, MD

CONTACT

[email protected]

514 340 8222 ext. 28799

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Diagnostic Test

Participants will not receive any intervention in this study. Participants will receive standard of care therapy

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

    Time frame: 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)

  2. 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rayan Kaedbey, MD FRCPC

CONTACT

[email protected]

514-340-8222

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study title

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

Acronym: TELO - DMRD

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 7, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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