Role of BCL-B in Multiple Myeloma

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT01270009
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other), U1065 team number 2 (Other)
60
1
36
1.7

Study Details

Study Description

Brief Summary

MM accounts for 10% of hematopoietic malignancies. Despite the use of various drug combinations in chemotherapy, life expectancy of MM patients does not exceed 7 years. Until now, lack of specific markers of the disease has not allowed efficient specific molecular targeting. In view of our preliminary results, the antiapoptotic protein Bcl-B could be a novel diagnostic and pronostic marker of MM. Therefore, our main objective will be to confirm that Bcl-B is indeed a novel diagnostic and pronostic marker and a new potential therapeutic target of MM. Targeting Bcl-2 family member's is a promising strategy for the treatment of hematopoietic malignancies. In this context, specific targeting of Bcl-B could improve the treatment of patients suffering MM. Of note, this could be achieved by converting the antiapoptotic function of Bcl-B to a proapoptotic one thanks to the use of small mimetic peptides derived from Nur77 one of its interactors.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Implication of the Antiapoptotic Protein BCL-B in the Pathogenesis of Multiple Myeloma
    Study Start Date :
    Nov 1, 2010
    Anticipated Primary Completion Date :
    Nov 1, 2013
    Anticipated Study Completion Date :
    Nov 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. To determine whether BCL-B is a survival factor in malignant plasmocytes, we will analyse the level of expression of Bcl-B at the both mRNA and protein levels in a cohort of MGUS and MM patients. [6 months]

      To determine whether BCL-B is a survival factor in malignant plasmocytes,we will analyse the level of expression of Bcl-B at the both mRNA and protein levels in a cohort of MGUS and MM patients. The implication of Bcl-B in malignant plasmocyte survival will be evaluated by loss of fucntion experiments (Si-RNA). This will also allow to determine whether Bcl-B is involved in the MGUS to MM transition.

    Secondary Outcome Measures

    1. To determine whether deregulation of BCL-B expression is associated to chimioresistances commonly observed in Multiple Myeloma, We will compare Bcl-B expression in MM patients either sensitive or resistant to conventional therapies. [6 months]

      To determine whether deregulation of BCL-B expression is associated to chimioresistances commonly observed in Multiple Myeloma, We will compare Bcl-B expression in MM patients either sensitive or resistant to conventional therapies. We will focuse on resistance to Velcade. we have also isolated established MM cell lines resistant to velcade in vitro which will be useful for the study with MM patients samples.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Patients with Multiple Myeloma and MGUS newly diagnosed at the Service de Medecine Interne-Cancerologie department of the Nice CHU

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Médecine interne et cancérologie - Hôpital de l'Archet Nice France 06002

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nice
    • Institut National de la Santé Et de la Recherche Médicale, France
    • U1065 team number 2

    Investigators

    • Principal Investigator: Jean-Gabriel FUZIBET, MD, CHU de Nice Service de Médecine Interne et Cancérologie Hôpital de l'Archet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nice
    ClinicalTrials.gov Identifier:
    NCT01270009
    Other Study ID Numbers:
    • 09-PP-10
    First Posted:
    Jan 5, 2011
    Last Update Posted:
    May 16, 2012
    Last Verified:
    May 1, 2012
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 16, 2012