An expanded treatment protocol of panobinostat in combination therapy for relapsed and relapsed and refractory (RR) cancer of plasma cells.

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2014-003239-21-NO
• Date of registration: 28/10/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: An expanded treatment protocol of panobinostat in combination therapy for relapsed and relapsed and refractory (RR) cancer of plasma cells.
• Scientific title: An open-label, multi-center, expanded treatment protocol of oral panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and relapsed and refractory multiple myeloma
• Date of first enrolment: 25/06/2015
• Target sample size: 314
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003239-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Brazil, Canada, Colombia, Denmark, France, Germany, India, Korea, Republic of, Mexico, Netherlands, Norway, Slovakia, Sweden, Taiwan, Venezuela, Bolivarian Republic of

Contacts

• Name: Medisinsk informasjon
• Affiliation: Novartis Norge AS

• Name: Medisinsk informasjon
• Affiliation: Novartis Norge AS

Key inclusion & exclusion criteria

Inclusion criteria:
- Patient with diagnosis of multiple myeloma, based on IMWG definitions
- Patient requires retreatment
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of = 2
- Absolute neutrophil count (ANC) = 1.0 x 109 /L
- Platelet count = 100 x 109 /L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 214

Exclusion criteria:
- Patient has shown intolerance or has any contraindications to bortezomib, dexamethasone or panobinostat
- Patient is refractory to panobinostat
- Patient has grade = 2 peripheral neuropathy
- Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted)
- Patient requires medication with a risk of prolonging the QT interval or inducing Torsades de pointes



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple myeloma
MedDRA version: 17.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Farydak
Product Code: LBH589
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PANOBINOSTAT
CAS Number: 404950-80-7
Current Sponsor code: LBH589
Other descriptive name: (2E)-N-Hydroxy-3-[4-({[2-(2-methyl-1H-indol-3-yl)ethyl]amino}methyl)phenyl]prop-2-
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Velcade
Product Name: Bortezomib
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 1-

Trade Name: Dexametason Abcur 1 mg
Product Name: Dexametason
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Dexametason Abcur 4 mg
Product Name: Dexametason
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Primary Outcome(s)

Main Objective: - To provide multiple myeloma patients early access to treatment with panobinostat and to further evaluate safety of panobinostat when used in combination with BTZ/Dex

Timepoint(s) of evaluation of this end point: discontinuation or deaths or after 16 cycles

Primary end point(s): AEs, Grade 3&4 AEs & SAEs, events of special interest, AEs leading to discontinuation, and deaths.

Secondary Objective: Secondary:
- To assess the efficacy of panobinostat when used in combination with BTZ/DEX by overall response rate (CR, nCR or PR) and progression-free survival per EBMT criteria

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: discontinuation or deaths or after 16 cycles

Secondary end point(s): Secondary:
- Overall response rate per modified EBMT criteria by investigator assessment
- Progression-free survival (PFS) based on investigator-assessed progression per modified EBMT criteria

Secondary ID(s)

2014-003239-21-AT

CLBH589D2001X

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact: