Use Lay Language. HA Score to Identify Myeloma Patients W... | NCT03515915

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

NCT03515915

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

May 11, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Patients With Recurrent or Refractory Multiple Myeloma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2018Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Apr 23, 2018

First Submission Date that Met QC Criteria

Apr 23, 2018

First Posted Date

May 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2018

Last Update Posted Date

May 11, 2018Actual

Name	Class
Poitiers University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Relapsed/refractory multiple myeloma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JEROME MOREAUX, PhD	Contact	467337903	33	j-moreaux@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
JEROME MOREAUX, PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided