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: 17 July 2017
• Main ID: EUCTR2014-003239-21-AT
• Date of registration: 22/10/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services 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: 05/12/2014
• Target sample size: 200
• 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, Jordan, Korea, Republic of, Mexico, Netherlands, Norway, Slovakia, Sweden, Taiwan, Venezuela, Bolivarian Republic of

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Pharma GmbH

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Patient with diagnosis of multiple myeloma, based on IMWG definitions, that is relapsed or relapsed and refractory to at least two prior regimens including bortezomib and an immunomodulatory agent.
a. Relapsed, defined by disease that recurred in a patient that responded under at least two prior regimens including bortezomib and an immunomodulatory agent, by reaching a MR or better, and had not progressed under current therapy or up to 60 days of last dose of this therapy. Patients previously treated with bortezomib are eligible.
b. Relapsed-and-refractory to a therapy, provided that patient meets both conditions:
•patient has relapsed to at least two prior regimens including bortezomib and an immunomodulatory agent
•and patient was refractory to at least two prior regimens including bortezomib and an immunomodulatory agent by either not reaching a MR, or progressed while under this therapy, or within 60 days of its last dose. Patients previously treated with bortezomib are eligible even if they are deemed refractory.

- 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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

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: 18.1 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: Farydak
Product Code: LBH589
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PANOBINOSTAT
CAS Number: 404950-80-7
Current Sponsor code: LBH589
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: Farydak
Product Code: LBH589
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PANOBINOSTAT
CAS Number: 404950-80-7
Current Sponsor code: LBH589
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-

Primary Outcome(s)

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

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 in patients with multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

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)

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

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

Secondary ID(s)

CLBH589D2001X

Source(s) of Monetary Support

Novartis Pharma Services AG