Panobinostat Post Authorization Safety Study, a non-interventional study of panobinostat in combination with bortezomib and dexamethasone in patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)

Study identification

• EU PAS number:
  EUPAS18261
• Study ID:
  34837
• Official title and acronym:
  Panobinostat Post Authorization Safety Study, a non-interventional study of panobinostat in combination with bortezomib and dexamethasone in patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Greece
• Study description:
  This Post Authorization Safety Study is a non interventional study conducted in Europe, of panobinostat in combination with bortezomib and dexamethasone in patients with Relapsed and/or Refractory Multiple Myeloma.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 46 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/04/2015

Actual: 09/01/2016

Study start date

Planned: 20/04/2017

Actual: 02/05/2017

Data analysis start date

Planned: 14/11/2022

Actual: 31/03/2019

Date of final study report

Planned: 14/05/2023

Actual: 29/11/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CLBH589D2408