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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02290431
Other study ID # CLBH589D1201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 16, 2014
Est. completion date December 25, 2018

Study information

Verified date October 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 25, 2018
Est. primary completion date December 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LBH589 (panobinostat)
Panobinostat (PAN) capsules were supplied at dose strengths of 10 mg and 15 mg. and dosed at 20mg during treatment phase 1 (21 days) and treatment phase 2 (42 days)
bortezomib
Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) & treatment phase 2 (42 days).
dexamethasone
Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days & treatment phase 2 (42 days)

Locations

Country Name City State
Japan Novartis Investigative Site Aomori
Japan Novartis Investigative Site Fukuoka city Fukuoka
Japan Novartis Investigative Site Higashiibaraki-gun Ibaraki
Japan Novartis Investigative Site Kashiwa-city Chiba
Japan Novartis Investigative Site Kobe-city Hyogo
Japan Novartis Investigative Site Koto ku Tokyo
Japan Novartis Investigative Site Kyoto-city Kyoto
Japan Novartis Investigative Site Maebashi city Gunma
Japan Novartis Investigative Site Matsuyama-city Ehime
Japan Novartis Investigative Site Nagoya-city Aichi
Japan Novartis Investigative Site Niigata
Japan Novartis Investigative Site Ogaki-city Gifu
Japan Novartis Investigative Site Okayama city Okayama
Japan Novartis Investigative Site Sendai-shi Miyagi
Japan Novartis Investigative Site Shibukawa-city Gunma
Japan Novartis Investigative Site Shibuya Tokyo
Japan Novartis Investigative Site Shinjuku ku Tokyo
Japan Novartis Investigative Site Suita city Osaka
Japan Novartis Investigative Site Tachikawa Tokyo
Japan Novartis Investigative Site Tokushima

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response. after 24 weeks (8 cycles; cycle = 21 days)
Secondary Progression Free Survival (PFS) PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment duration of study up to approx. 4 years
Secondary Overall Response Rate (ORR) ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment 24 weeks (8 cycles; cycle = 21 days)
Secondary Overall Survival (OS) OS is defined as time from first dose of study treatment to death up to 30 days after end of study, approx. 4 years
Secondary Minimal Response Rate (MRR) Per Investigator MRR is based on modified EBMT criteria per investigator assessment after 24 weeks (8 cycles; cycle = 21 days)
Secondary Time to Response (TTR) Per Investigator TTR is defined as the time from the date of first dose of study treatment to first documented response (PR or nCR or CR) per modified EBMT criteria as assessed by investigator duration of study up to approx. 4 years
Secondary Time to Progression/Relapse (TTP) Per Investigator TTP is defined as the time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse duration of study up to approx. 4 years
Secondary Duration of Response (DOR) Per Investigator DOR is defined as the time from date of the first documented CR/nCR or PR to the date of the first documented progression or relapse or death due to MM duration of study up to approx. 4 years
Secondary Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL. Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156
Secondary Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
Secondary Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax Cmax: The maximum (peak) observed plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
Secondary Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax Tmax: The time to reach maximum (peak) plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ. Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
Secondary Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2 T1/2: The elimination half-life associated with the terminal slope (Lambda_z) of a semi logarithmic concentration-time curve Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
Secondary Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z Lambda_z: The terminal elimination rate constant (h-1) Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
Secondary Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F CL/F: The apparent total body clearance of drug from the plasma Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
Secondary Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F Vz/F: The apparent volume of distribution during terminal phase (associated with Lambda_z) Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose
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