Multiple MyelomaNCT01270009
Role of BCL-B in Multiple Myeloma
An observational study of Multiple Myeloma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine interne et cancérologie - Hôpital de l'Archet
Nice, 06002
About this study
Official title: Implication of the Antiapoptotic Protein BCL-B in the Pathogenesis of Multiple Myeloma
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.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Gabriel FUZIBET, MD, Principal investigator, CHU de Nice Service de Médecine Interne et Cancérologie Hôpital de l'Archet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270009
- Sponsor's protocol ID
- 09-PP-10
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2011
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of the Antiapoptotic Protein BCL-B in the Pathogenesis of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01270009
- Acronym / sponsor ID
- 09-PP-10
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Myeloma and MGUS newly diagnosed at the Service de Medecine Interne-Cancerologie department of the Nice CHU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Gabriel FUZIBET, MD principal investigator
CHU de Nice Service de Médecine Interne et Cancérologie Hôpital de l'Archet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.