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
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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