Actively Recruiting
Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Newly Diagnosed Multiple Myeloma Patients
Led by Universiteit Antwerpen · Updated on 2025-07-28
120
Participants Needed
4
Research Sites
345 weeks
Total Duration
On this page
Sponsors
U
Universiteit Antwerpen
Lead Sponsor
F
FWO Research Fund Flanders
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study investigates newly diagnosed multiple myeloma patients following standard of care treatment. The primary endpoint of the study is to determine minimal residual disease (MRD) by combining 2 techniques in order to better predict progression free survival (PFS) of a patient. Secondary endpoint is to gain more insight into diagnostic features to better stratify patients based on risk factors for early relapse. Both endpoints could lead to a more patient specific treatment in the future. Participants will be followed throughout their standard of care treatment. This treatment consists of indcution chemotherapy, followed by autologous stem cell transplant (ASCT), followed by lenalidomide maintenance therapy. * Before start of induction chemotherapy the patient will receive a whole-body FDG PET/LDCT scan and an additional bone marrow aspirate sample will be taken during a routine bone marrow punction. This sample will be used for whole exome sequencing (WES). * For those patients who achieve at least a very good partial response (VGPR) after induction chemotherapy and ASCT a repeat whole body FDG PET/LDCT scan will be performed before start of maintenance therapy. This scan will be repeated for a third time after 1 year of maintenance therapy. Besides this, an additional bone marrow aspirate sample will be taken for MRD detection. This will be done before start of maintenance therapy, after 1 year of maintenance therapy and after 2 years of maintenance therapy. MRD detection is done by next generation flow cytometery (NGF). * During mantenance therapy patient follow-up will be performed at least every 3 months to determine best response to therapy or possible relapse (based on routine lab information). * Those patients who do not achieve VGPR or better will not need to receive a whole body FDG PET/CT scan and MRD detection by flow cytometry, but these patients will undergo the same follow-up during maintenance therapy. * In case of relapse, for all patients, an additional bone marrow aspirate sample will be taken for WES (during a routine bone marrow investigation).
CONDITIONS
Official Title
Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Newly Diagnosed Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT
- Patients can be included after ASCT prior to maintenance if baseline FDG-PET CT shows FDG avid disease
- Baseline 18F-FDG PET/WBLDCT scan before treatment start or within 7 days after start showing FDG avid disease
- WHO performance status 0-2 (higher allowed if due to disease and approved by physician)
- Age 18 years or older
- Life expectancy greater than 12 months by clinical judgement
- Achieved at least very good partial response (VGPR) after induction chemotherapy and ASCT
- Received at least one 28-day cycle of lenalidomide as maintenance therapy after ASCT
- No new therapy until clinical relapse
You will not qualify if you...
- Any physical or physiological condition affecting study adherence, such as severe claustrophobia or inability to lie still for 30 minutes
- Uncontrolled diabetes
- History of other malignancies except non-melanoma skin cancer, carcinoma in situ of cervix, or other effectively treated malignancy in remission for over 5 years or likely cured
- Pregnant or breastfeeding
- Refusal or inability to provide written informed consent
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Universitair ziekenhuis Antwerpen
Antwerp, Antwerpen, Belgium, 2650
Actively Recruiting
2
Universitair ziekenhuis Gent
Ghent, Oost Vlaandere, Belgium, 9000
Actively Recruiting
3
Universitair Ziekenhuis Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
4
AZ Sint-Jan Brugge
Bruges, West-Vlaandere, Belgium, 8000
Actively Recruiting
Research Team
S
Sofie De Rechter
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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