Combining PET scans and bone marrow genetic testing to better predict relapse in newly diagnosed multiple myeloma patients
Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Myeloma
This project tries combining FDG PET/LDCT imaging and whole-exome sequencing of bone marrow to detect minimal residual disease and better predict progression for transplant-eligible newly diagnosed multiple myeloma patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiteit Antwerpen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Antwerp, Antwerpen and 3 other locations) |
| Trial ID | NCT07087964 on ClinicalTrials.gov |
What this trial studies
Patients are followed prospectively through standard-of-care induction chemotherapy, autologous stem cell transplant (ASCT), and lenalidomide maintenance while researchers collect baseline whole-body FDG PET/LDCT and a bone marrow aspirate for whole-exome sequencing. The primary aim is to combine two MRD-detection techniques to improve prediction of progression-free survival, and the secondary aim is to identify diagnostic features that better stratify risk of early relapse. Inclusion requires FDG-avid disease on baseline PET and transplant eligibility, and patients who achieve at least a VGPR after induction and ASCT and start lenalidomide maintenance contribute to the primary endpoint. The observational design means no experimental therapy is given beyond standard clinical care.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with transplant-eligible newly diagnosed multiple myeloma who have FDG-avid disease on baseline PET, WHO performance status 0–2, an expected life expectancy over 12 months, and who are scheduled for induction chemotherapy followed by ASCT and lenalidomide maintenance.
Not a fit: Patients who are not transplant-eligible, who lack FDG-avid disease on PET, who cannot undergo PET or bone marrow sampling, or who do not achieve the required response after ASCT are less likely to benefit from the study's MRD-based predictions.
Why it matters
Potential benefit: If successful, this approach could enable more personalized treatment by identifying patients at higher risk of relapse who may need intensified or alternative therapy.
How similar studies have performed: Prior work shows FDG PET and molecular MRD measures each have prognostic value in multiple myeloma, but combining PET with whole-exome sequencing for MRD-guided risk prediction is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT. Remark: patiënts can also be included after ASCT, prior to maintenance therapy, if a baseline FDG-PET CT scan showing FDG avid disease is available. * Baseline 18F-FDG PET/WBLDCT scan should be performed before start of treatment (preferably) or within 7 days after start of treatment. Scan must show FDG avid disease (=at least 1 FL ≥ DS3 and/or diffuse bone marrow involvement). * WHO performance status 0-2 (WHO \> 2 can be allowed if due to underlying disease and after discussion with the physician). * Age ≥ 18 years * Life expectancy \> 12 months, based on clinical judgement. Eligibility criteria for the primary endpoint * achieving at least a VGPR after induction chemotherapy and ASCT according to the standard IMWG response criteria. * received at least one (28-day) cycle of lenalidomide as maintenance therapy after ASCT. No new therapy can be given until clinical relapse. Exclusion Criteria: * Any physical or physiological condition that may affect adherence to the study protocol, e.g. severe claustrophobia or the inability to lie still for 30 minutes. * uncontrolled diabetes * History of concomitant presence of any other malignancy, except for: * non-melanoma skin cancer * carinoma in situ of the cervix * any other effectively treated malignancy that has been in remission for \> 5 years or that is highly likely to be cured at the time of enrollment. * pregnant or breastfeeding * refusal or inability to provide written informed consent
Where this trial is running
Antwerp, Antwerpen and 3 other locations
- Universitair ziekenhuis Antwerpen — Antwerp, Antwerpen, Belgium (Recruiting)
- Universitair ziekenhuis Gent — Ghent, Oost Vlaandere, Belgium (Recruiting)
- Universitair Ziekenhuis Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
- AZ Sint-Jan Brugge — Bruges, West-Vlaandere, Belgium (Recruiting)
Study contacts
- Study coordinator: Sofie De Rechter
- Email: sofie.derechter@uantwerpen.be
- Phone: 03 821 31 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.