Patients With Recurrent or Refractory Multiple Myeloma Clinical Trial
Official title:
Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor
| NCT number | NCT03515915 |
| Other study ID # | UF9760 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 23, 2018 |
| Est. completion date | December 31, 2019 |
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Relapsed/refractory multiple myeloma - Aged 18 years or more with no upper age limit - Have signed an informed consent Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 1 day | |
| Secondary | Progression free survival will be monitored. | Progression free survival will be monitored. | 1 day |