Clinical trial NCT02290431: Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Official title: A Phase II, Multi-center, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapse/Refractory Multiple Myeloma
Keywords: LBH589
panobinostat
bortezomib
dexamethasone
Phase II
bortezomib and dexamethasone
Japanese patients
relapsed/refractory multiple myeloma
Panobinostat (PAN)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy and safety of panobinostat in combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* Patient had a previous diagnosis of multiple myeloma
* Patient required retreatment for multiple myeloma
* Patient had measurable M component in serum or urine at study screening

Exclusion Criteria:

* Primary refractory disease (patients that never reached at least an minor response for over 60 days under any prior therapy)
* Patient who had been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
* Patient received prior treatment with DAC inhibitors including panobinostat
* Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG

Primary outcomes:
measure: Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate
timeFrame: after 24 weeks (8 cycles; cycle = 21 days)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: duration of study up to approx. 4 years
measure: Overall Response Rate (ORR)
timeFrame: 24 weeks (8 cycles; cycle = 21 days)
measure: Overall Survival (OS)
timeFrame: up to 30 days after end of study, approx. 4 years
measure: Minimal Response Rate (MRR) Per Investigator
timeFrame: after 24 weeks (8 cycles; cycle = 21 days)
measure: Time to Response (TTR) Per Investigator
timeFrame: duration of study up to approx. 4 years
measure: Time to Progression/Relapse (TTP) Per Investigator
timeFrame: duration of study up to approx. 4 years
measure: Duration of Response (DOR) Per Investigator
timeFrame: duration of study up to approx. 4 years
measure: Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156
measure: Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
timeFrame: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
measure: Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax
timeFrame: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
measure: Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax
timeFrame: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
measure: Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2
timeFrame: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
measure: Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z
timeFrame: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
measure: Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F
timeFrame: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
measure: Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F
timeFrame: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa-city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama-city
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Ogaki-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Shibukawa-city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Sendai-shi
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Okayama city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Suita city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Koto ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shibuya
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Aomori
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Tokushima
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Suzuki K, Sunami K, Matsumoto M, Maki A, Shimada F, Suzuki K, Shimizu K. Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Panobinostat in Combination with Bortezomib and Dexamethasone in Japanese Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma. Acta Haematol. 2021;144(3):264-274. doi: 10.1159/000508529. Epub 2020 Dec 4.