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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01270009
Other study ID # 09-PP-10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2010
Est. completion date November 2013

Study information

Verified date January 2024
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Patients with Multiple Myeloma and MGUS newly diagnosed at the Service de Medecine Interne-Cancerologie department of the Nice CHU

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Médecine interne et cancérologie - Hôpital de l'Archet Nice

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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. 6 months
Secondary 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. 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. 6 months
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