NCT02290431 · REGISTRY CONDITION SEARCH

Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-11-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Minimal Response Rate (MRR) Per Investigator

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outcome · POSTED

Time to Response (TTR) Per Investigator

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outcome · POSTED

Time to Progression/Relapse (TTP) Per Investigator

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outcome · POSTED

Duration of Response (DOR) Per Investigator

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outcome · POSTED

Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score

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outcome · POSTED

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf

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outcome · POSTED

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax

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outcome · POSTED

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax

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outcome · POSTED

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2

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outcome · POSTED

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z

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outcome · POSTED

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F

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outcome · POSTED

Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
intervention Names
Drug: LBH589 (panobinostat)
Drug: bortezomib
Drug: dexamethasone
label
LBH589 + bortezomib + dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
LBH589 + bortezomib + dexamethasone
description
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)
name
LBH589 (panobinostat)
type
DRUG
arm Group Labels
LBH589 + bortezomib + dexamethasone
description
Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) \& treatment phase 2 (42 days).
name
bortezomib
type
DRUG
arm Group Labels
LBH589 + bortezomib + dexamethasone
description
Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days \& treatment phase 2 (42 days)
name
dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 31
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate
time Frame
after 24 weeks (8 cycles; cycle = 21 days)

secondary Outcomes

description
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
measure
Progression Free Survival (PFS)
time Frame
duration of study up to approx. 4 years
description
ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
measure
Overall Response Rate (ORR)
time Frame
24 weeks (8 cycles; cycle = 21 days)
description
OS is defined as time from first dose of study treatment to death
measure
Overall Survival (OS)
time Frame
up to 30 days after end of study, approx. 4 years
description
MRR is based on modified EBMT criteria per investigator assessment
measure
Minimal Response Rate (MRR) Per Investigator
time Frame
after 24 weeks (8 cycles; cycle = 21 days)
description
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
measure
Time to Response (TTR) Per Investigator
time Frame
duration of study up to approx. 4 years
description
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
measure
Time to Progression/Relapse (TTP) Per Investigator
time Frame
duration of study up to approx. 4 years
description
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
measure
Duration of Response (DOR) Per Investigator
time Frame
duration of study up to approx. 4 years
description
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.
measure
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
time Frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156
description
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.
measure
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
time Frame
Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
description
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.
measure
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax
time Frame
Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
description
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.
measure
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax
time Frame
Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose
description
T1/2: The elimination half-life associated with the terminal slope (Lambda\_z) of a semi logarithmic concentration-time curve
measure
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2
time Frame
Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose

Full study description

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.

Source references

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.
pmid
33279887
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice