Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Last updated: March 8, 2020
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Cancer

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT01023308
CLBH589D2308
2009-015507-52
  • Ages > 18
  • All Genders

Study Summary

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient has a previous diagnosis of multiple myeloma.

  2. Patient requires retreatment for multiple myeloma

  3. Patient has measurable M component in serum or urine at study screening

Exclusion

Exclusion Criteria:

  1. Patient who has progressed under all prior lines of anti MM therapy

  2. Patient who has been treated by bortezomib before, and did not reach at least a minorresponse under this therapy, or progressed under it or within 60 days of last dose

  3. Patient has shown intolerance to bortezomib or to dexamethasone or components of thesedrugs or has any contraindication to one or the other drug , following locallyapplicable prescribing information

  4. Patient received prior treatment with DAC inhibitors including panobinostat

  5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG

  6. Patient taking medications with relative risk of prolonging the QT interval orinducing Torsade de pointes

  7. Female patient who is pregnant or breast feeding or with childbearing potential andnot willing to use a double method of contraception up to 3 months after the end ofstudy treatment. Male patient who is not willing to use a barrier method ofcontraception up to 3 months after the end of study treatment. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 767
Study Start date:
December 21, 2009
Estimated Completion Date:
July 30, 2015

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    Site Not Available

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Phoenix, Arizona
    United States

    Site Not Available

  • Arizona Oncology Associates, PC

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Little Rock Hematology and Oncology Associates

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Novartis Investigative Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Kaiser Permanente Oncology Research

    Bellflower, California 90706
    United States

    Site Not Available

  • Mena, Raul R.

    Burbank, California 91505
    United States

    Site Not Available

  • Novartis Investigative Site

    Concord, California 94520
    United States

    Site Not Available

  • S.C.P.M.G. Fontana

    Fontana, California 92335
    United States

    Site Not Available

  • Novartis Investigative Site

    Loma Linda, California
    United States

    Site Not Available

  • Novartis Investigative Site

    Los Angeles, California 90027
    United States

    Site Not Available

  • Dr. Sunil C. Patel, MD

    Ontario, California 91761
    United States

    Site Not Available

  • Ventura County Hematology and Oncology

    Oxnard, California 93030
    United States

    Site Not Available

  • Bay Area Cancer Research Group

    Pleasant Hill, California 94523
    United States

    Site Not Available

  • Novartis Investigative Site

    Sacramento, California 95816
    United States

    Site Not Available

  • Novartis Investigative Site

    San Diego, California 92120
    United States

    Site Not Available

  • Kaiser Permante Clinical Trials

    San Francisco, California 94080
    United States

    Site Not Available

  • Novartis Investigative Site

    Stanford, California 94304
    United States

    Site Not Available

  • Kaiser Permanente - Woodland Hills

    Woodland Hills, California 91367
    United States

    Site Not Available

  • Hematology Oncology PC

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • Novartis Investigative Site

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Memorial Regional Cancer Center Memorial Cancer Center

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Novartis Investigative Site

    Lake Worth, Florida 33467
    United States

    Site Not Available

  • Novartis Investigative Site

    Lakewood, Florida 33461
    United States

    Site Not Available

  • Advanced Medical Specialties

    Miami, Florida 33176
    United States

    Site Not Available

  • Novartis Investigative Site

    Miami Shores, Florida 33138
    United States

    Site Not Available

  • Innovative Medical Research of South Florida

    North Miami Beach, Florida 33179
    United States

    Site Not Available

  • Oncology Hematology Consultants

    Pembroke, Florida 33467
    United States

    Site Not Available

  • Oncology Hematology Consultants

    Pembrook Pines, Florida 33028
    United States

    Site Not Available

  • Lake County Hematology and Oncolgy

    Tavares, Florida 32778
    United States

    Site Not Available

  • Novartis Investigative Site

    Athens, Georgia 30607
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Novartis Investigative Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Northwest Georgia Oncology Centers

    Marrietta, Georgia 30060
    United States

    Site Not Available

  • Novartis Investigative Site

    Chicago, Illinois 60546
    United States

    Site Not Available

  • Novartis Investigative Site

    Marywood, Illinois 60153
    United States

    Site Not Available

  • Loyola University

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Novartis Investigative Site

    Quincy, Illinois 62301
    United States

    Site Not Available

  • Novartis Investigative Site

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Louisana State University Health Sciences Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Washington County Hospital

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Maryland Oncology Hematology

    Owning Mills, Maryland 21117,
    United States

    Site Not Available

  • Novartis Investigative Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Alliance Hematology Oncology

    Westminister, Maryland 21157
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Kalamazoo Hematology and Oncology

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Novartis Investigative Site

    Southfield, Michigan
    United States

    Site Not Available

  • Novartis Investigative Site

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Minnestoa Oncology Hematology

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Minnesota Oncology Hematology PA

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Novartis Investigative Site

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Park Nicolette Institute-Fravenshuh Cancer Center

    St Louis Park, Minnesota 55426
    United States

    Site Not Available

  • Park Nicollet Institute Park Nicollet Medical Ctr (4)

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Novartis Investigative Site

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Novartis Investigative Site

    East Orange, New Jersey 07018-1095
    United States

    Site Not Available

  • San Juan Oncology Associates

    Farmington, New Mexico 87401
    United States

    Site Not Available

  • New York Oncology Hematology

    Albany, New York 12206
    United States

    Site Not Available

  • New York Hematology, PC

    Amsterdam, New York 12010
    United States

    Site Not Available

  • Montefiore Medical Center ONCO site H009

    Bronx, New York 10467
    United States

    Site Not Available

  • Novartis Investigative Site

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Mount Kisco Medical Group

    Mt. Kisco, New York 10549
    United States

    Site Not Available

  • New York University Medical Center New York Oncology Hematology,

    New York, New York 10016
    United States

    Site Not Available

  • New York Oncology Hematology, P.C. NYOH Rexford

    Troy, New York 12180
    United States

    Site Not Available

  • Cancer Care Institute of Carolina

    Aiken, North Carolina 29801
    United States

    Site Not Available

  • Cancer Care of Western North Carolina, PA

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Cancer Care of Western NC

    Ashville, North Carolina 28801
    United States

    Site Not Available

  • Novartis Investigative Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Brody School of Medicine

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • New Bern Cancer Care

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center Oncology

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Novartis Investigative Site

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Legacy Pharma Research

    Bismark, North Dakota 58501
    United States

    Site Not Available

  • Mid-Ohio Oncology Hematology Inc. The Mark H. Zangmeister Center

    Colombus, Ohio 43219
    United States

    Site Not Available

  • Mid Ohio Oncology/Hematology

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Novartis Investigative Site

    Dayton, Ohio 45429
    United States

    Site Not Available

  • Hematology and Oncology of Dayton

    Kettering, Ohio 14545
    United States

    Site Not Available

  • Novartis Investigative Site

    Middletown, Ohio 45042
    United States

    Site Not Available

  • Oklahoma U Health Science Center

    Oklahoma City, Oklahoma 73104-5043
    United States

    Site Not Available

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Novartis Investigative Site

    East Providence, Rhode Island 02915
    United States

    Site Not Available

  • Novartis Investigative Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Novartis Investigative Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • South Texas Institute of Cancer S. Tex Inst.- Corpus Christi

    Corpus Christi, Texas 78405
    United States

    Site Not Available

  • US Oncology Central Monitoring

    Dallas, Texas 75246
    United States

    Site Not Available

  • Novartis Investigative Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Novartis Investigative Site

    Houston, Texas 77030
    United States

    Site Not Available

  • West Texas Cancer Center

    Odessa, Texas 79761
    United States

    Site Not Available

  • Cancer Outreach Associates

    Abingdon, Virginia 24211
    United States

    Site Not Available

  • Cancer Outreach Associates

    Abington, Virginia 24211
    United States

    Site Not Available

  • Medical Oncology & Hematology Associates of Northern VA Medical Oncology & Hema Assoc

    Reston, Virginia 20190
    United States

    Site Not Available

  • Novartis Investigative Site

    Kennewick, Washington 99336
    United States

    Site Not Available

  • Novartis Investigative Site

    Seattle, Washington 98104
    United States

    Site Not Available

  • NW Medical Specialties

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Novartis Investigative Site

    Walla Walla, Washington 33962
    United States

    Site Not Available

  • Novartis Investigative Site

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • Dean Hematology & Oncology Clinic

    Madison, Wisconsin 53717
    United States

    Site Not Available

  • Pro Health Care Inc.

    Waukesha, Wisconsin 53188
    United States

    Site Not Available

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