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NCT06170151 Clinical Trial

Role of18F-FDG PET-CT for Assessing and Predicting Response to Daratumumab and for Prognosis With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Role of18F-FDG PET-CT for Assessing and Predicting Response to Daratumumab and for Prognosis With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06170151
Other study ID # DaRMy PET
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 24, 2021
Est. completion date December 1, 2022

Study information
Verified date December 2023
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Diagnostic accuracy
evaluate the role of 18F-FDG PET-CT for assessing early response after 6 months of treatment in patients with relapsed/refractory multiple myeloma.

Locations
Country Name City State
Italy Irccs San Raffaele Milano Italia

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 18F-FDG PET-CT to predicting response to treatment and to predicting prognosis in patients with relapsed/refractory multiple myeloma. 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. 1 year
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