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Validation of a Personalised Medicine Tool for Multiple Myeloma That Predicts Treatment Effectiveness in Patients (MMpredict)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409692
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Mario Boccadoro, University of Turin, Italy

Study Description
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Brief Summary:

The consortium aims to commercialise the MMpredictor as a personalised medicine tool that predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients. MM is the second most common form of blood cancer contributing to 15% of all blood cancers and ~1,5% and 2% of all cancer deaths annually in the EU and US, respectively.

Patients show a large variability in treatment response and side effects due to tumour heterogeneity and the patient's intrinsic characteristics. Therefore, not every treatment will be suitable for each patient, and treatment strategies are often based on trial-and-error. The availability of multiple (>20) treatment options complicates treatment decision-making even more. With the current development of many more promising treatments, there is an urgent unmet clinical need for a diagnostic assay that supports personalised cancer treatment in order to improve patient health outcomes, prevent side effects and reduce healthcare costs.

SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling. An addendum for new intended use will be filed to the current in vitro diagnostic (IVD) registration, while renaming the test to MMpredictor. The project will also focus on positioning the test as a cost-effective IVD test for personalised medicine, that will increase health outcome and quality of life of patients and reduce healthcare costs.

The consortium consists of a life science SME specialised in molecular diagnostics, clinical centres with world renowned KOLs, a leading health economic institute, and a European MM patient advocacy organisation combining all the required complementary expertise to successfully bring the MMpredictor to market.


Condition or disease Intervention/treatment
Multiple Myeloma Diagnostic Test: Gene Expression Profiling

Study Design
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Study Type : Observational
Actual Enrollment : 278 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Validation of a Personalised Medicine Tool for Multiple Myeloma That Predicts Treatment Effectiveness in Patients
Actual Study Start Date : June 14, 2017
Actual Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Gene Expression Profiling
    SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling.

Outcome Measures
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Primary Outcome Measures :
  1. MMpredictor as a personalised medicine tool [ Time Frame: 1 year ]
    The main objective of the MMpredict project is to commercialise the MMpredictor as a personalised medicine tool that predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients.


Secondary Outcome Measures :
  1. - Genetic subtyping with the MMprofiler of 800 bio-banked MM patient samples [ Time Frame: 2 years ]
  2. - Clinical validation of genetic subtypes correlating with specific treatment effect [ Time Frame: 2 years ]
  3. - Establish a treatment decision matrix that will guide physicians in treatment decision-making [ Time Frame: 2 years ]
  4. - Perform a Medical Technology Assessment (MTA) to evaluate health economic benefits [ Time Frame: 2 years ]
  5. - File addendum to current CE-IVD registration, while also renaming the test to "MMpredictor" [ Time Frame: 2 years ]
  6. - Develop and execute commercialisation and marketing plan for the MMpredictor [ Time Frame: 2 years ]

Eligibility Criteria
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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:   Non-Probability Sample
Study Population
MM patients enrolled in clinical trials that have been conducted over the past 5 years.
Criteria

Inclusion Criteria:

  • The bio-banked MM patient samples and clinical data will be obtained from previous European clinical trials that have been conducted over the past 5 years within the participating clinical centres and other clinical centers. The samples were not collected for the purposes of this project. The subjects from which the data was initially taken cannot be identified from the data/records. However, the patients from the above mentioned trial have explicitly consented for the use of their samples for other (future) clinical research purposes.

Exclusion Criteria:

-

Contacts and Locations
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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): NCT03409692


Locations
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Italy
University of Turin
Turin, Italy, 10125
Sponsors and Collaborators
Mario Boccadoro
More Information
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Responsible Party: Mario Boccadoro, Director of Department of Molecular Biotechnology and Health Sciences, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT03409692    
Other Study ID Numbers: Horizon2020 - FTI Pilot Study
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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