Use Lay Language. HA Score to Identify Myeloma Patients Who Could Benefit From HDACi Treatment
- Conditions
- Patients With Recurrent or Refractory Multiple Myeloma
- Registration Number
- NCT03515915
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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 (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Relapsed/refractory multiple myeloma
- Aged 18 years or more with no upper age limit
- Have signed an informed consent
NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method Progression free survival will be monitored. 1 day Progression free survival will be monitored.
Trial Locations
- Locations (1)
Uhmontpellier
🇫🇷Montpellier, France