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

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ClinicalTrials.gov Identifier: NCT02290431
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Relapse/Refractory Multiple Myeloma Drug: LBH589 (panobinostat) Drug: bortezomib Drug: dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 16, 2014
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : December 25, 2018


Arm Intervention/treatment
Experimental: LBH589 + bortezomib + dexamethasone
LBH589 will be administered in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
Drug: LBH589 (panobinostat)
Drug: bortezomib
Drug: dexamethasone



Primary Outcome Measures :
  1. Near Complete Response (nCR) plus Complete Response (CR) rate [ Time Frame: after 24 weeks ]
    nCR plus CR rate after 8 cycles of therapy as defined by the modified EBMT criteria. Cycle = 21 days


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 30 months ]
    PFS, defined as time from first dose of study treatment to progression or death due to any cause, as assessed by investigator

  2. Overall Response Rate (ORR) [ Time Frame: 30 months ]
    ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment

  3. Overall survival (OS) [ Time Frame: 30 months ]
    OS, defined as time from first dose of study treatment to death

  4. Minimal Response Rate (MRR) [ Time Frame: 30 months ]
    MRR is based on modified EBMT criteria per investigator assessment

  5. Time to response (TTR) [ Time Frame: 30 months ]
    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

  6. Time to progression/relapse (TTP) [ Time Frame: 30 months ]
    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

  7. Duration of response (DOR) [ Time Frame: 30 months ]
    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

  8. Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments [ Time Frame: 30 months ]
    Safety of combination therapy (panobinostat+bortezomib+dexamethasone) as assessed by toxicity, which will be assessed using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale for Adverse Events and for laboratory assessments (v4.03) that include biochemistry, hematology, urinalysis; special safety assessments that include LVEF, Thyroid function Creatinine clearance and ECGs (electrocardiograms).

  9. Quality of Life (QoL) [ Time Frame: Baseline, 30 months ]
    QoL as measured by FACT/GOG-NTX. Calculated scores and changes from baseline will be summarized by visit.

  10. Composite PharmacoKinetics (PK) of Panobinostat and bortezomib [ Time Frame: Predose, Day1, Day3, Day3, Day8, Day9 and Day10 ]
    Composite PharmacoKinetics (PK) of Panobinostat and bortezomib as assessed by Cmax, Tmax, AUC, T1/2.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a previous diagnosis of multiple myeloma
  • Patient requires retreatment for multiple myeloma
  • Patient has 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 has 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 has impaired cardiac function, or a prolonged QTc interval at screening ECG

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290431


Locations
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Japan
Nagoya City University Hospital
Nagoya City, Aichi, Japan, 467-8602
Novartis Investigative Site
Kashiwa-city, Chiba, Japan, 277-8567
Matsuyama Red Cross Hospital
Matsuyama-City, Ehime, Japan, 790-8524
Novartis Investigative Site
Fukuoka city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Ogaki-city, Gifu, Japan, 503-8502
Gunma University Hospital
Maebashi-city, Gunma, Japan, 371-8511
Novartis Investigative Site
Shibukawa-city, Gunma, Japan, 377-0280
Kobe City Medical Center General Hospital
Kobe, Hyogo, Japan, 650-0047
Mito Medical Center
Higashiibaraki-gun, Ibaraki, Japan, 311-3193
University Hospital, Kyoto Prefectural, University of Medicine
Kamigyo-ku, Kyoto, Japan, 602-8566
Novartis Investigative Site
Sendai-shi, Miyagi, Japan, 983 8520
Niigatq Cancer Ce3nter Hospital
Kawagishi-cho, Chuo-ku, Niigata, Japan, 951-8566
Novartis Investigative Site
Okayama city, Okayama, Japan, 701-1192
Osaka University Hospital
Yamadaoka, Suita-City, Osaka, Japan, 565-0871
Tokushima University Hospital
Tokushima-City, Tokushima, Japan, 770-8503
Novartis Investigative Site
Koto ku, Tokyo, Japan, 135 8550
Japanese Red Cross Medical Center
Shibuya-Ku, Tokyo, Japan, 150-8935
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, Japan, 162-8655
Novartis Investigative Site
Tachikawa, Tokyo, Japan, 190-0014
Novartis Investigative Site
Aomori, Japan, 030 8553
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02290431     History of Changes
Other Study ID Numbers: CLBH589D1201
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LBH589,
panobinostat,
bortezomib,
dexamethasone,
Phase II
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Bortezomib
Panobinostat
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents