Role of18F-FDG PET-CT for Assessing and Predicting Response to Daratumumab and for Prognosis With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT06170151
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
Positron Emission Tomography - Computed Tomography (PET-CT) using fluorine-18 fluorodeoxyglucose is a functional imaging diagnostic tool which is widely used In several neoplastic conditions, at initial staging, for restaging in suspected disease relapse and for assessing the response to treatment. Most patients with multiple myeloma (MM) exhibit a high-glycolytic activity rate and therefore they are FOG-avid, especially at the disease relapse. The priceless value of 18F-FOG PET-CT in the therapeutic assessment for several treatment schemes, including aSCT, has been highlighted by several studies: particularly, the occurrence of negative PET-CT after a double aSCT in MM patients with clinical complete response or very good partial response positively correlates with favourable PFS and overall survival (OS). likewise, persistence of 18F-FDG avid disease in MM patients achieving a clinical complete response constitutes a poor prognostic factor. Primary objective of this prospective, observational, non-pharmacological, multicentric study is to evaluate the role of 18F-FDG PET-CT for assessing early response after 6 months of treatment with daratumumab in patients with .relapsed/refractory MM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- patients with refractory multiple myeloma who relapsed after therapy with daratumumab in combination with dexamethasone + bortezomib or dexamethasone + lenalidomide;
- patients capable of expressing informed consent.
- patients with clinical contraindications to the administration of daratumumab;
- patients with coexisting non-hematological neoplastic condition;
- patients< 18 years;
- patients uncapable of expressing informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 18F-FDG PET-CT to predicting response to treatment and to predicting prognosis in patients with relapsed/refractory multiple myeloma. 1 year Positron Emission Tomography - Computed Tomography (PET-CT) using fluorine-18 fluorodeoxyglucose to assess early response after 6 months of treatment with daratumumab in 10 patients with relapsed/refractory multiple myeloma.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Irccs San Raffaele
🇮🇹Milano, Italia, Italy