Myelomatosis Myelomatosis
Conditions
Interventions
None listed
Sponsors
Universiteit Antwerpen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Transplant eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction therapy followed by autologous stam cell transplantation. - Baseline 18F-FDG PET/CT scan should be performed. Prior to start of treatment, or within 7 days after the start. To be eligible for the primary endpoint, the scan should show FDG avid disease. - WHO performance status 0-2 (WHO >2 can be allowed if due to underlying disease and after discussion with the physician) - Age 18 years or older - life expectancy > 12 months, based on clinical judgement. - achieving at least VGPR after induction therapy and ASCT according to the standard IMWG response criteria (necessary for primary endpoint only). - received at least one (28-day) cycle of (daratumumab)lenalidomide as maintenance therapy after ASCT. No new therapy can be given until clinical relapse (necessary for primary endpoint only).
Exclusion criteria
Exclusion criteria: - any physical or physiological condition that may affect adherence to the study protocol (severe claustrophobia, inability to lie still for 30 minutes) - uncontrolled diabetes - history or concomitant presence of any other malignancy, except for: non-melanoma skin cancer, carcinoma 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 time of enrollment. - pregnant or breast feeding - no informed consent - participation in other (interventional) clinical trials without permission of the study team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to evaluate the prognostic value of FDG-PET combined with NGF in patients achieving VGPR or better after induction chemotherapy and ASCT and before lenalidomide maintenance therapy. We hypothesize that only patients who have no evidence of disease on both NGF and FDG-PET have a durable response with a 2y PFS of 90% compared to 50% in pts who have evidence of disease on at least one modality. PFS is defined as the time from achieving >= VGPR and confirmation of absence of MRD (landmark) to first documentation of objective progressive disease or death due to any cause, whichever occurs first. The <10-5 MRD level is used to define BM-NGF MRD-negativity. A Deauville score=3 threshold will be used to define FDG-PET MRD-negativity, but alternatives will also be evaluated (other DS, more quantitative measures like SUV) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is to implement WES, FDG PET/CT and Radiomics at baseline to improve risk-stratification. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactL. Grave
Amsterdam UMC
Outcome results
None listed