Combining PET scans and bone marrow genetic testing to better predict relapse in newly diagnosed multiple myeloma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients are followed prospectively through standard-of-care induction chemotherapy, autologous stem cell transplant (ASCT), and lenalidomide maintenance while researchers collect baseline whole-body FDG PET/LDCT and a bone marrow aspirate for whole-exome sequencing. The primary aim is to combine two MRD-detection techniques to improve prediction of progression-free survival, and the secondary aim is to identify diagnostic features that better stratify risk of early relapse. Inclusion requires FDG-avid disease on baseline PET and transplant eligibility, and patients who achieve at least a VGPR after induction and ASCT and start lenalidomide maintenance contribute to the primary endpoint. The observational design means no experimental therapy is given beyond standard clinical care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT. Remark: patiënts 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 ≥ 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 ≥ 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

Where it's running

• Universitair ziekenhuis Antwerpen
  Antwerp, Antwerpen, Belgium Recruiting
• Universitair ziekenhuis Gent
  Ghent, Oost Vlaandere, Belgium Recruiting
• Universitair Ziekenhuis Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting
• AZ Sint-Jan Brugge
  Bruges, West-Vlaandere, Belgium Recruiting

Study contacts

• Study coordinator: Sofie De Rechter
• Email: sofie.derechter@uantwerpen.be
• Phone: 03 821 31 43

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fewer-doses daratumumab added to VRd for newly diagnosed multiple myeloma

  This study tests whether a less-frequent daratumumab dosing plan added to VRd can help patients with newly diagnosed multiple myeloma achieve more MRD negativity.

  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra and 1 other locations · NCT07891923

• AZD0120 consolidation vs ASCT in transplant-eligible newly diagnosed multiple myeloma

  This study tests whether AZD0120 given as consolidation can work as well as or better than traditional autologous stem cell transplant in transplant-eligible patients with newly diagnosed multiple myeloma.

  Recruiting at 2 sites Phase 3 AstraZeneca · Gilbert, Arizona and 113 other locations · NCT07735637

• First-line RN1201 CAR-T for newly diagnosed multiple myeloma

  This early, small study tests a once-dosed, donor-derived CAR-T therapy (RN1201) in adults with newly diagnosed multiple myeloma to see if it is safe and if patients respond.

  Recruiting Phase 1 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07652138

• First-line immunotherapy in Chinese adults with newly diagnosed multiple myeloma

  This study will test how first-line immunotherapy treatments—including anti-CD38 antibodies, proteasome inhibitors, and IMiDs—work in adults newly diagnosed with multiple myeloma in China over one year.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07296627

• Using 18F-fluciclovine PET/CT to detect multiple myeloma

  This study is testing a new imaging method using a special tracer to see if it can better detect multiple myeloma in adults compared to the current method.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06103838

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.