Clinical trial NCT02403102: Imageguided Theranostics in Multiple Myeloma
Official title: Imageguided Theranostics in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Myeloma
Keywords: Magnetic Resonance Imaging
Myeloma
Autograft
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: National Institute for Health Research, United Kingdom
name: Royal Marsden NHS Foundation Trust
First posted: 2015-03-31
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with myeloma planned for autograft.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years post autograph
Secondary outcomes:
measure: Use multivariate/univariate analysis to identify the best single or combination MRI parameter(s) to predict disease status at 2 years
timeFrame: 2 years post autograph
measure: Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years.
timeFrame: 2 years post autograph
measure: Calculate PFS for patients grouped by optimal cut-off.
timeFrame: 2 years post autograph
measure: Overall survival (OS) in patients with residual disease on WB-DWI post induction and 3 months post autograft.
timeFrame: 2 years post autograph
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Christina Messiou, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messiou C, Porta N, Sharma B, Levine D, Koh DM, Boyd K, Pawlyn C, Riddell A, Downey K, Croft J, Morgan V, Stern S, Cheung B, Kyriakou C, Kaczmarek P, Winfield J, Blackledge M, Oyen WJG, Kaiser MF. Prospective Evaluation of Whole-Body MRI versus FDG PET/CT for Lesion Detection in Participants with Myeloma. Radiol Imaging Cancer. 2021 Sep;3(5):e210048. doi: 10.1148/rycan.2021210048.