Multiple MyelomaTELO - DMRDNCT05530096
Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD
An observational study of Multiple Myeloma, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to Sep 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant having confirmed Multiple Myeloma diagnosis will be enrolled in this study.
Who may be able to join
- 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
Who cannot join
- Failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Rayan Kaedbey, MD, 514 340 8222 ext. 28799, rayan.kaedbey@mcgill.ca
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Standard of care
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDiagnostic test
Participants will not receive any intervention in this study. Participants will receive standard of care therapy
| Study group | Role | What they receive |
|---|---|---|
| MRD level group | Participants will be defined as diagnosed with multiple myeloma Receives: Diagnostic Test: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- 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
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 May 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rayan Kaedbey, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Rayan Kaedbey, Principal investigator, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530096
- Sponsor's protocol ID
- Telo Genomics Study
- Acronym
- TELO - DMRD
- Status last verified
- Mar 2025
- First submitted
- 31 Aug 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detect and Profile Multiple Myeloma Measurable Residual Disease (MRD )Prognostics for Monitoring Post-transplant Multiple Myeloma (MM) Patients Receiving Maintenance Therapy.
- ClinicalTrials.gov ID
- NCT05530096
- Acronym / sponsor ID
- TELO - DMRD / Telo Genomics Study
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose :
Detect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD level group | – | Diagnostic Test: Standard of careParticipants will be defined as diagnosed with multiple myeloma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant having confirmed Multiple Myeloma diagnosis will be enrolled in this study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careParticipants will not receive any intervention in this study. Participants will receive standard of care therapy | Diagnostic test | MRD level group |
Primary outcome
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rayan Kaedbey principal investigator
Sir Mortimer B. Davis - Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rayan Kaedbey, MD FRCPC (514-340-8222, rayan.kaedbey.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.