Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD

Multiple Myeloma Clinical Trial

— TELO - DMRD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05530096
• Other study ID #: Telo Genomics Study
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: September 2028

Study information

• Verified date: October 2022
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Rayan Kaedbey, MD FRCPC
• Phone: 514-340-8222
• Email: rayan.kaedbey.med[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose :

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2028
• Est. primary completion date: September 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Diagnostic Test:
• Standard of care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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