Imageguided Theranostics in Multiple Myeloma (iTIMM)

December 13, 2022 updated by: Nandita deSouza, Institute of Cancer Research, United Kingdom

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with myeloma planned for autograft.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: 2 years post autograph
2 years post autograph

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Use multivariate/univariate analysis to identify the best single or combination MRI parameter(s) to predict disease status at 2 years
Time Frame: 2 years post autograph
2 years post autograph
Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years.
Time Frame: 2 years post autograph
2 years post autograph
Calculate PFS for patients grouped by optimal cut-off.
Time Frame: 2 years post autograph
2 years post autograph
Overall survival (OS) in patients with residual disease on WB-DWI post induction and 3 months post autograft.
Time Frame: 2 years post autograph
2 years post autograph

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Cancer Research, United Kingdom

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal Marsden NHS Foundation Trust
Cancer Research UK
National Institute for Health Research, United Kingdom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina Messiou, Dr, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15/LO/0036 CCR4236

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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