Role of BCL-B in Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
U1065 team number 2
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01270009
First received: January 4, 2011
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implication of the Antiapoptotic Protein BCL-B in the Pathogenesis of Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01270009

Contacts
Contact: Jean-Gabriel FUZIBET, MD 0492 03 58 24 fuzibet.jg@chu-nice.fr

Locations
France
Service de Médecine interne et cancérologie - Hôpital de l'Archet Recruiting
Nice, France, 06002
Contact: Jean-Gabriel Fuzibet, MD    04 92 03 58 24    fuzibet.jg@chu-nice.fr   
Contact: Frederic Luciano, PhD    04 93 37 77 58    fluciano@unice.fr   
Principal Investigator: Jean-Gabriel Fuzibet, MD         
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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01270009     History of Changes
Other Study ID Numbers: 09-PP-10
Study First Received: January 4, 2011
Last Updated: May 15, 2012
Health Authority: France: French Data Protection Authority

Additional relevant 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

ClinicalTrials.gov processed this record on September 18, 2014