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Imageguided Theranostics in Multiple Myeloma (iTIMM)

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ClinicalTrials.gov Identifier: NCT02403102
Recruitment Status : Recruiting
First Posted : March 31, 2015
Last Update Posted : September 15, 2017
Sponsor:
Collaborators:
Cancer Research UK
National Institute for Health Research, United Kingdom
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom

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.


Condition or disease
Cancer Myeloma

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imageguided Theranostics in Multiple Myeloma
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years. [ Time Frame: 2 years post autograph ]
  3. Calculate PFS for patients grouped by optimal cut-off. [ Time Frame: 2 years post autograph ]
  4. Overall survival (OS) in patients with residual disease on WB-DWI post induction and 3 months post autograft. [ Time Frame: 2 years post autograph ]

Biospecimen Retention:   Samples With DNA
Patients who undergo autograft have regular blood tests and marrow sampling and we will use these samples, to look at other factors which influence patient outcomes such as genetics, without compromising routine care. Some of the genetic tests performed on the bone marrow are not routine so we will obtain additional consent to do this.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with myeloma planned for autograft.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403102


Contacts
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Contact: Christina Messiou, Dr 02086613339 Christina.Messiou@icr.ac.uk
Contact: Tiffany Rushen 02086613339 tiffany.rushen@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Christina Messiou, Dr    0208 661 3216    christina.messiou@rmh.nhs.uk   
Contact: Delilah Harding    0208 6613339    Delilah.Harding@rmh.nhs.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
National Institute for Health Research, United Kingdom
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Christina Messiou, Dr Royal Marsden NHS Foundation Trust

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Responsible Party: NdeSouza, Professor of Translational Imaging, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02403102     History of Changes
Other Study ID Numbers: 15/LO/0036 CCR4236
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by NdeSouza, Institute of Cancer Research, United Kingdom:
Magnetic Resonance Imaging
Myeloma
Autograft

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases