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Trial record 95 of 138 for:    lbh-589

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 : Recruiting
First Posted : November 14, 2014
Last Update Posted : October 26, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 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 : May 17, 2013
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : July 8, 2019


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


Contacts
Contact: Novartis Pharmaceuticals +81337978748 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals novartis.email@novartis.com

Locations
Japan
Nagoya City University Hospital Recruiting
Nagoya City, Aichi, Japan, 467-8602
Novartis Investigative Site Completed
Kashiwa-city, Chiba, Japan, 277-8567
Matsuyama Red Cross Hospital Recruiting
Matsuyama-City, Ehime, Japan, 790-8524
Novartis Investigative Site Terminated
Fukuoka city, Fukuoka, Japan, 812-8582
Novartis Investigative Site Recruiting
Ogaki-city, Gifu, Japan, 503-8502
Gunma University Hospital Recruiting
Maebashi-city, Gunma, Japan, 371-8511
Principal Investigator: Hiroshi Handa, M.D.         
Novartis Investigative Site Recruiting
Shibukawa-city, Gunma, Japan, 377-0280
Novartis Investigative Site Completed
Kure-city, Hiroshima, Japan, 737-0023
Kobe City Medical Center General Hospital Recruiting
Kobe, Hyogo, Japan, 650-0047
Mito Medical Center Recruiting
Higashiibaraki-gun, Ibaraki, Japan, 311-3193
University Hospital, Kyoto Prefectural, University of Medicine Recruiting
Kamigyo-ku, Kyoto, Japan, 602-8566
Novartis Investigative Site Recruiting
Sendai-shi, Miyagi, Japan, 983 8520
Niigatq Cancer Ce3nter Hospital Recruiting
Kawagishi-cho, Chuo-ku, Niigata, Japan, 951-8566
Novartis Investigative Site Completed
Okayama-city, Okayama, Japan, 701-1192
Osaka University Hospital Recruiting
Yamadaoka, Suita-City, Osaka, Japan, 565-0871
Novartis Investigative Site Completed
Utsunomiya-shi, Tochigi, Japan, 320-0834
Tokushima University Hospital Recruiting
Tokushima-City, Tokushima, Japan, 770-8503
Novartis Investigative Site Completed
Koto-ku, Tokyo, Japan, 135 8550
Japanese Red Cross Medical Center Recruiting
Shibuya-Ku, Tokyo, Japan, 150-8935
Center Hospital of the National Center for Global Health and Medicine Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8655
Principal Investigator: Akiyoshi Miwa, M.D.         
Novartis Investigative Site Recruiting
Tachikawa, Tokyo, Japan, 190-0014
Novartis Investigative Site Recruiting
Aomori, Japan, 030 8553
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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: October 26, 2018
Last Verified: October 2018
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


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:
Panobinostat
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 acetate
Dexamethasone
Bortezomib
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