CanceriTIMMNCT02403102
Imageguided Theranostics in Multiple Myeloma
An observational study of Cancer and Myeloma, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2015to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with myeloma planned for autograft.
Who may be able to join
- All patients over the age of 18 with multiple myeloma planned for autograft.
Who cannot join
- MRI incompatible metal implants
- Claustrophobia
- Diagnosis of other malignancy within 5 years.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
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.
Read more
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.
- Keywords
- Magnetic Resonance Imaging, Myeloma, Autograft
- Medical subject headings
- Neoplasms, Neoplasms, Plasma Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years post autograph
Secondary outcomes (4)
Use multivariate/univariate analysis to identify the best single or combination MRI parameter(s) to predict disease status at 2 years
Measured: 2 years post autograph
Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years.
Measured: 2 years post autograph
Calculate PFS for patients grouped by optimal cut-off.
Measured: 2 years post autograph
Overall survival (OS) in patients with residual disease on WB-DWI post induction and 3 months post autograft.
Measured: 2 years post autograph
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start26 Mar 2015
- Primary completionFeb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Christina Messiou, Dr, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403102
- Sponsor's protocol ID
- 15/LO/0036 CCR4236
- Acronym
- iTIMM
- Status last verified
- May 2021
- First submitted
- 19 Mar 2015
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Basty N, Kaiser MF, Pawlyn C, Boyd KD, Smith K, Thomas K, Porta N, Meo D, Emsley R, Winfield J, Dragan A, Doran S, Koh DM, Whitcher B, Messiou C. AI derived Whole-Body MRI metrics in multiple myeloma patients reveal unique insights into body composition and outcomes. Blood Adv. 2026 Jul 8:bloodadvances.2026020852. doi: 10.1182/bloodadvances.2026020852. Online ahead of print.
PubMed 42418394Messiou 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.
PubMed 34559006
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imageguided Theranostics in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02403102
- Acronym / sponsor ID
- iTIMM / 15/LO/0036 CCR4236
- Keywords
- Magnetic Resonance Imaging, Myeloma, Autograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Cancer Research UK, National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myeloma planned for autograft.
Key inclusion criteria (1 listed)
- All patients over the age of 18 with multiple myeloma planned for autograft.
Key exclusion criteria (3 listed)
- MRI incompatible metal implants
- Claustrophobia
- Diagnosis of other malignancy within 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years.
Time frame: 2 years post autograph
Calculate PFS for patients grouped by optimal cut-off.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 42418394Basty N, Kaiser MF, Pawlyn C, Boyd KD, Smith K, Thomas K, Porta N, Meo D, Emsley R, Winfield J, Dragan A, Doran S, Koh DM, Whitcher B, Messiou C. AI derived Whole-Body MRI metrics in multiple myeloma patients reveal unique insights into body composition and outcomes. Blood Adv. 2026 Jul 8:bloodadvances.2026020852. doi: 10.1182/bloodadvances.2026020852. Online ahead of print.
- Derived from this study: PubMed 34559006Messiou 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.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Messiou, Dr principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Myeloma, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years post autograph). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403102, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.