Multiple myeloma MedDRA version: 18.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
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)
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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 ;Primary end point(s): AEs, Grade 3&4 AEs & SAEs, events of special interest, AEs leading to discontinuation, and deaths.;Timepoint(s) of evaluation of this end point: discontinuation or deaths or after 16 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria, Brazil, Canada, Colombia, Denmark, France, Germany, India, Jordan, Korea, Republic of, Mexico, Netherlands, Norway, Slovakia, Sweden, Taiwan, Venezuela, Bolivarian Republic of
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed