Imageguided Theranostics in Multiple Myeloma

Cancer Clinical Trial

— iTIMM  

Official title:

Imageguided Theranostics in Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403102
• Other study ID #: 15/LO/0036 CCR4236
• Status: Completed
• Start date: March 26, 2015
• Est. completion date: February 28, 2021

Study information

• Verified date: May 2021
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Theranostics is the use of a diagnostic test to decide which patients will benefit from a certain treatment. The current standard treatment for patients with myeloma is induction chemotherapy followed by peripheral stem cell transplant. Although there are options for timing of treatments, patient outcomes are variable and the investigators do not currently know which patients benefit from which treatment schedule. There is evidence to suggest that residual disease on imaging after treatment is an indicator for a worse prognosis, however the best time point for this imaging is currently not known. This study is designed to show if there is an optimum time point for correlation between imaging and prognosis. Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and the investigators will confirm this when patients are first diagnosed, by performing both FDG PET/CT and whole body diffusion weighted MRI. Patients will then be followed up with whole body diffusion weighted MRI after induction chemotherapy and 3 months post autograft. The investigators will look at the amount of disease present on these scans and correlate this with outcomes. There are likely to be other factors which influence patient outcomes (such as genetics) and the investigators will also look at some of these. Patients who undergo autograft have regular blood tests and marrow samples taken as part of routine care, the investigators will use some of these samples (without compromising the patients treatment) to analyses some of these other factors. If the investigators are able to determine a correlation of genetic factors with outcome this information could be used in future research. Theranostics is the use of a diagnostic test to decide which patients will benefit from a certain treatment. The current standard treatment for patients with myeloma is induction chemotherapy followed by peripheral stem cell transplant. Although there are options for timing of treatments, patient outcomes are variable and the investigators do not currently know which patients benefit from which treatment schedule. There is evidence to suggest that residual disease on imaging after treatment is an indicator for a worse prognosis, however the best time point for this imaging is currently not known. This study is designed to show if there is an optimum time point for correlation between imaging and prognosis. Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and the investigators will confirm this when patients are first diagnosed, by performing both FDG PET/CT and whole body diffusion weighted MRI. Patients will then be followed up with whole body diffusion weighted MRI after induction chemotherapy and 3 months post autograft. The investigators will look at the amount of disease present on these scans and correlate this with outcomes. There are likely to be other factors which influence patient outcomes (such as genetics) and the investigators will also look at some of these. Patients who undergo autograft have regular blood tests and marrow samples taken as part of routine care, the investigators will use some of these samples (without compromising the patients treatment) to analyses some of these other factors. If the investigators are able to determine a correlation of genetic factors with outcome this information could be used in future research.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 28, 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients over the age of 18 with multiple myeloma planned for autograft.

Exclusion Criteria:

• MRI incompatible metal implants
• Claustrophobia
• Diagnosis of other malignancy within 5 years.

Related Conditions & MeSH terms

• Cancer
• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Cancer Research UK, National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construct a ROC curve and calculate area under the curve (AUC) to show that the burden of disease at 3 months post autograft (WB-DWI score) is predictive of disease status at 2 years.		2 years post autograph
Secondary	Use multivariate/univariate analysis to identify the best single or combination MRI parameter(s) to predict disease status at 2 years		2 years post autograph
Secondary	Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years.		2 years post autograph
Secondary	Calculate PFS for patients grouped by optimal cut-off.		2 years post autograph
Secondary	Overall survival (OS) in patients with residual disease on WB-DWI post induction and 3 months post autograft.		2 years post autograph