Panobinostat with bortezomib and dexamethasone in relapsed or relapsed-and-refractory multiple myeloma

A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001564-19-BE

Enrollment

240

Registered

2016-03-15

Start date

2016-05-17

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Interventions

Trade Name: Farydak 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 descripti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Multiple Myeloma as per IMWG 2014 definition - Requiring treatment for relapsed or relapsed/refractory disease - Measurable disease based on central protein assessment - 1 to 4 prior lines of therapy - Prior IMiD exposure - Acceptable lab values prior to starting study treatment Other protocol-defined inclusion criteria may apply. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 190

Exclusion criteria

Exclusion criteria: - Primary refractory myeloma - Refractory to bortezomib i.e. patients who progressed while receiving salvage therapy with BTZ, or patients who progressed within 60 days of their most recent BTZ containing treatment. - Concomitant anti-cancer therapy (other than BTZ/Dex and bisphosphonates) - Prior treatment with DAC inhibitors - Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 month prior to screening) - Unresolved diarrhea = CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease) Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To assess overall response rate (ORR) up to 8 cycles;Secondary Objective: - To assess overall response rate (ORR) - To assess the individual iCR, sCR, CR, VGPR rates - To assess progression free survival (PFS) - To assess overall survival (OS) - To evaluate overall safety of the combination of PAN, BTZ and Dex - To assess pharmacokinetics - To assess exposure-response (efficacy and safety) relationship - To assess Time to Progression (TTP), Time to Response (TTR), Duration of Response (DOR) - To assess health-related quality of life (HRQoL);Primary end point(s): - ORR (according to IMWG criteria by IRC assessment) comprised of immunophenotypic CR (iCR), stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR);Timepoint(s) of evaluation of this end point: approximately after 30 months	—

Measure

Time frame

Main Objective: - To assess overall response rate (ORR) up to 8 cycles;Secondary Objective: - To assess overall response rate (ORR) - To assess the individual iCR, sCR, CR, VGPR rates - To assess progression free survival (PFS) - To assess overall survival (OS) - To evaluate overall safety of the combination of PAN, BTZ and Dex - To assess pharmacokinetics - To assess exposure-response (efficacy and safety) relationship - To assess Time to Progression (TTP), Time to Response (TTR), Duration of Response (DOR) - To assess health-related quality of life (HRQoL);Primary end point(s): - ORR (according to IMWG criteria by IRC assessment) comprised of immunophenotypic CR (iCR), stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR);Timepoint(s) of evaluation of this end point: approximately after 30 months

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Secondary

Measure	Time frame
Secondary end point(s): - ORR (according to IMWG criteria by IRC assessment) - iCR, sCR, CR, VGPR rates (according to IMWG criteria by IRC assessment) - PFS (according to IMWG criteria by IRC assessment) - OS - AEs (graded by CTCAE v4.03), SAEs Abnormalities in vital signs, ECG parameters, and laboratory test values. This will include events up to 30 days after discontinuation of study treatment. - Cmax (PAN, BTZ), C24h (PAN), Cmin (BTZ) and AUC0-8h (PAN, BTZ) - ORR, Grade 3/4 Thrombocytopenia, Grade 3/4 Diarrhea (relationship with PAN, BTZ PK parameters derived from NCA or Pop PK analysis) - TTP, TTR, DOR (according to IMWG criteria by IRC assessment) - HRQoL as measured by EORTC QLQ-C30 and FACT/GOG-Ntx;Timepoint(s) of evaluation of this end point: - best ORR: approximately after 70 months - individual iCR, sCR, CR, VGPR rates: approximatively after 30 and 70 months - PFS: approximatively after 30 and 70 months - OS: approximatively after 30 and 70 months - Overall safety of combination of PAN, BTZ and Dex: approximatively after 30 and 70 months - Pharmacokinetics: approximatively after 30 months - Exposure-response:a pproximatively after 30 months - TTP, TTR, DOR: approximatively after 30 and 70 months - HRQoL: approximatively after 30 and 70 months	—

Measure

Time frame

Secondary end point(s): - ORR (according to IMWG criteria by IRC assessment) - iCR, sCR, CR, VGPR rates (according to IMWG criteria by IRC assessment) - PFS (according to IMWG criteria by IRC assessment) - OS - AEs (graded by CTCAE v4.03), SAEs Abnormalities in vital signs, ECG parameters, and laboratory test values. This will include events up to 30 days after discontinuation of study treatment. - Cmax (PAN, BTZ), C24h (PAN), Cmin (BTZ) and AUC0-8h (PAN, BTZ) - ORR, Grade 3/4 Thrombocytopenia, Grade 3/4 Diarrhea (relationship with PAN, BTZ PK parameters derived from NCA or Pop PK analysis) - TTP, TTR, DOR (according to IMWG criteria by IRC assessment) - HRQoL as measured by EORTC QLQ-C30 and FACT/GOG-Ntx;Timepoint(s) of evaluation of this end point: - best ORR: approximately after 70 months - individual iCR, sCR, CR, VGPR rates: approximatively after 30 and 70 months - PFS: approximatively after 30 and 70 months - OS: approximatively after 30 and 70 months - Overall safety of combination of PAN, BTZ and Dex: approximatively after 30 and 70 months - Pharmacokinetics: approximatively after 30 months - Exposure-response:a pproximatively after 30 months - TTP, TTR, DOR: approximatively after 30 and 70 months - HRQoL: approximatively after 30 and 70 months

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Countries

Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Lebanon, Netherlands, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Thailand, Turkey, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

+4161324 1111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026