Positron emission tomography with innovative laboratory techniques for improved risk and disease assessment in myeloma

Recruiting

Conditions: Myelomatosis
10018865

Registration Number: NL-OMON53692

Lead Sponsor: niversiteit Antwerpen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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. 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.
- 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 (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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is to evaluate the prognostic value of<br /><br>FDG-PET combined with NGF in patients achieving VGPR or better after induction<br /><br>chemotherapy and ASCT and before lenalidomide maintenance therapy. We<br /><br>hypothesize that only patients who have no evidence of disease on both NGF and<br /><br>FDG-PET have a durable response with a 2y PFS of 90% compared to 50% in pts who<br /><br>have evidence of disease on at least one modality. PFS is defined as the time<br /><br>from achieving >= VGPR and confirmation of absence of MRD (landmark) to first<br /><br>documentation of objective progressive disease or death due to any cause,<br /><br>whichever occurs first. The <10-5 MRD level is used to define BM-NGF<br /><br>MRD-negativity. A Deauville score=3 threshold will be used to define FDG-PET<br /><br>MRD-negativity, but alternatives will also be evaluated (other DS, more<br /><br>quantitative measures like SUV)</p><br>

Secondary Outcome Measures