NCT01270009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

January 4, 2011

Last Update Submit

January 25, 2024

Conditions

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine interne et cancérologie - Hôpital de l'Archet

Nice, 06002, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jean-Gabriel FUZIBET, MD

    CHU de Nice Service de Médecine Interne et Cancérologie Hôpital de l'Archet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 26, 2024

Record last verified: 2024-01

Locations