RecruitingNCT07087964

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

Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Myeloma


Sponsor

Universiteit Antwerpen

Enrollment

120 participants

Start Date

May 16, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses advanced PET/CT imaging and new laboratory blood tests to better assess the extent of disease and predict outcomes in people who are newly diagnosed with multiple myeloma (a blood cancer) and are eligible for a stem cell transplant. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma and are eligible for stem cell transplantation - You are scheduled for induction chemotherapy followed by autologous stem cell transplant - Alternatively, you may enroll after transplant but before starting maintenance therapy, if your initial imaging showed active disease **You may NOT be eligible if...** - You are not eligible for a stem cell transplant - You have already started maintenance therapy post-transplant without a qualifying baseline scan - You are unable to undergo PET/CT imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

Universitair ziekenhuis Antwerpen

Antwerp, Antwerpen, Belgium

Universitair ziekenhuis Gent

Ghent, Oost Vlaandere, Belgium

Universitair Ziekenhuis Leuven

Leuven, Vlaams-Brabant, Belgium

AZ Sint-Jan Brugge

Bruges, West-Vlaandere, Belgium

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NCT07087964


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