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Relapse/Refractory Multiple MyelomaPhase 2NCT02290431

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

A Phase 2 study testing LBH589 (panobinostat), bortezomib and dexamethasone in people with Relapse/Refractory Multiple Myeloma, run by Novartis Pharmaceuticals at 20 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapse/Refractory Multiple Myeloma
What is being tested?
LBH589 (panobinostat), bortezomib and dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
20 sitesJapan
Study dates
16 Dec 2014to 25 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • Novartis Investigative Site

    Aomori, 030 8553

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8567

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047

  • Novartis Investigative Site

    Koto Ku, Tokyo, 135 8550

  • Novartis Investigative Site

    Kyoto, Kyoto, 602-8566

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-8524

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 467-8602

  • Novartis Investigative Site

    Niigata, 951-8566

  • Novartis Investigative Site

    Ōgaki, Gifu, 503-8502

  • Novartis Investigative Site

    Okayama, Okayama-ken, 701-1192

  • Novartis Investigative Site

    Sendai, Miyagi, 983 8520

  • Novartis Investigative Site

    Shibukawa, Gunma, 377-0280

  • Novartis Investigative Site

    Shibuya City, Tokyo, 150-8935

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162 8655

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Tachikawa, Tokyo, 190-0014

  • Novartis Investigative Site

    Tokushima, 770-8503

Other trials in Japan

About this study

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

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.

Being tested
LBH589 (panobinostat), bortezomib, dexamethasone
Keywords
LBH589, panobinostat, bortezomib, dexamethasone, Phase II, bortezomib and dexamethasone, Japanese patients, relapsed/refractory multiple myeloma, Panobinostat (PAN)
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LBH589 (panobinostat)Drug

    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)

  • bortezomibDrug

    Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) \& treatment phase 2 (42 days).

  • dexamethasoneDrug

    Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days \& treatment phase 2 (42 days)

Study groups in NCT02290431
Study groupRoleWhat they receive
LBH589 + bortezomib + dexamethasoneExperimentalParticipants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
Receives: Drug: LBH589 (panobinostat); Drug: bortezomib; Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: after 24 weeks (8 cycles; cycle = 21 days)

Secondary outcomes (15)

  1. 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

    Measured: duration of study up to approx. 4 years

  2. 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

    Measured: 24 weeks (8 cycles; cycle = 21 days)

  3. Overall Survival (OS)

    OS is defined as time from first dose of study treatment to death

    Measured: up to 30 days after end of study, approx. 4 years

  4. Minimal Response Rate (MRR) Per Investigator

    MRR is based on modified EBMT criteria per investigator assessment

    Measured: after 24 weeks (8 cycles; cycle = 21 days)

  5. 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

    Measured: duration of study up to approx. 4 years

  6. 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

    Measured: duration of study up to approx. 4 years

  7. 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

    Measured: duration of study up to approx. 4 years

  8. 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.

    Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156

  9. 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.

    Measured: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose

  10. 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.

    Measured: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose

  11. 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.

    Measured: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose

  12. 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

    Measured: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose

  13. Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z

    Lambda_z: The terminal elimination rate constant (h-1)

    Measured: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose

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

    CL/F: The apparent total body clearance of drug from the plasma

    Measured: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose

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

    Vz/F: The apparent volume of distribution during terminal phase (associated with Lambda_z)

    Measured: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2014 (estimated)
  2. Study start16 Dec 2014
  3. Primary completion29 Dec 2017
  4. Study completion25 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02290431
Sponsor's protocol ID
CLBH589D1201
Status last verified
Oct 2019
First submitted
24 Oct 2014
Last updated
18 Nov 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • 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.

    PubMed 33279887

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LBH589 (panobinostat), bortezomib and dexamethasone in people with Relapse/Refractory Multiple Myeloma, run by Novartis Pharmaceuticals at 20 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate (time frame: after 24 weeks (8 cycles; cycle = 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290431, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.

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