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Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Newly Diagnosed Multiple Myeloma Patients

Recruitingn/aAges 18 Years - anyAllUniversiteit Antwerpen
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In plain words

What the trial is, and whether it could suit you

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 b

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT. Remark: patiรซnts 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 โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Not listed
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Where

4 sites
Universitair ziekenhuis Antwerpen
Antwerp, Belgium
Universitair ziekenhuis Gent
Ghent, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
AZ Sint-Jan Brugge
Bruges, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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