The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MYeloma Resistance And Clonal Evolution (MYRACLE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807128
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

Condition or disease Intervention/treatment
Multiple Myeloma Other: No interventional study

Detailed Description:
The MYRACLE cohort study aims at including all patients (>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: MYeloma Resistance And Clonal Evolution
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : February 11, 2029
Estimated Study Completion Date : February 11, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: No interventional study
    No interventional study

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Describe the mechanisms of resistance of myeloma cells. [ Time Frame: Ten years ]
    Number of resistance.


Biospecimen Retention:   Samples With DNA
blood, urine, bone marrow

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

The study population corresponds to multiple myeloma patients managed in the hematology departments of the University Hospital of Nantes and the CHD of La Roche sur Yon.

Recruitment of the hematology departments of the University Hospital of Nantes and CHD of La Roche sur Yon makes it possible to envisage an annual recruitment of 60 new myeloma diagnoses, and an annual number of 80 relapses. These data are estimated from the number of files submitted to the Multidisciplinary Collaborative Meeting (RPN) and the annual inclusion number in clinical trials. This number represents a cohort of about 140 inclusions per year. The average number of visits can be estimated at 1.5 / year per patient.

Criteria

Inclusion Criteria:

  • Patient with diagnosis of multiple myeloma according to standard criteria
  • Age >18

Exclusion Criteria:

  • Minor patient
  • Patient under guardianship
  • Protected patient
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03807128


Contacts
Layout table for location contacts
Contact: Cyrille TOUZEAU, PU 02 40 08 32 71 cyrille.touzeau@chu-nantes.fr

Locations
Layout table for location information
France
La Roche sur Yon Hospital Departmental Recruiting
La Roche-sur-Yon, France, 85000
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Cyrille TOUZEAU, PU    02 53 48 24 05    cyrille.touzeau@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Cyrille TOUZEAU, PU Nantes University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03807128    
Other Study ID Numbers: RC18_0197
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Myeloma
Cohort
Resistance
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
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