Use Lay Language. HA Score to Identify Myeloma Patients Who Could Benefit From HDACi Treatment

Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03515915

Enrollment

Registered

2018-05-04

Start date

2018-04-23

Completion date

2019-12-31

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Recurrent or Refractory Multiple Myeloma

Keywords

multiple myeloma, HDAC inhibitor, Biomarker

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Relapsed/refractory multiple myeloma * Aged 18 years or more with no upper age limit * Have signed an informed consent

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Progression free survival will be monitored.	1 day	Progression free survival will be monitored.

Countries

France

Contacts

Primary ContactJEROME MOREAUX, PhD

j-moreaux@chu-montpellier.fr467337903

Outcome results