Patients With Recurrent or Refractory Multiple MyelomaNCT03515915
Use Lay Language. HA Score to Identify Myeloma Patients Who Could Benefit From HDACi Treatment
An observational study of Patients With Recurrent or Refractory Multiple Myeloma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Recurrent or Refractory Multiple Myeloma
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2018to 31 Dec 2019
- 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
- Adult, Older adult
Study population: Relapsed/refractory multiple myeloma
Who may be able to join
- Relapsed/refractory multiple myeloma
- Aged 18 years or more with no upper age limit
- Have signed an informed consent
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
JEROME MOREAUX, PhD, 467337903 ext. 33, j-moreaux@chu-montpellier.fr
About this study
Official title: Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor
Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens, including bortezomib and an immunomodulatory drug.
A GEP-based histone acetylation score allowing identification of MM patients with a poor prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al. BJC. 2013).
Our hypothesis is that the histone acetylation score could be promising to identify MM patients who could benefit from treatment with HDACi and the development of personalized treatment.
- Keywords
- multiple myeloma, HDAC inhibitor, Biomarker
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
Measured: 1 day
Secondary outcomes (1)
Progression free survival will be monitored.
Progression free survival will be monitored.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start23 Apr 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Recurrent or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Poitiers University Hospital
- Responsible party
- Sponsor
- Investigators
- JEROME MOREAUX, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515915
- Sponsor's protocol ID
- UF9760
- Status last verified
- Apr 2018
- First submitted
- 23 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor
- ClinicalTrials.gov ID
- NCT03515915
- Acronym / sponsor ID
- UF9760
- Keywords
- multiple myeloma, HDAC inhibitor, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Poitiers University Hospital
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 May 2018 (actual)
- 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.
Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens, including bortezomib and an immunomodulatory drug.
A GEP-based histone acetylation score allowing identification of MM patients with a poor prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al. BJC. 2013).
Our hypothesis is that the histone acetylation score could be promising to identify MM patients who could benefit from treatment with HDACi and the development of personalized treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Relapsed/refractory multiple myeloma
Key inclusion criteria (3 listed)
- Relapsed/refractory multiple myeloma
- Aged 18 years or more with no upper age limit
- Have signed an informed consent
Key exclusion criteria (1 listed)
- NA
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
Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
Time frame: 1 day
Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
1 secondary outcome
Progression free survival will be monitored.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
JEROME MOREAUX, PhD study director
University Hospital, Montpellier
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 Patients With Recurrent or Refractory Multiple Myeloma, run by University Hospital, Montpellier 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 11 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JEROME MOREAUX, PhD (467337903 ext. 33, j-moreaux@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value (time frame: 1 day). 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 11 May 2018.