Last updated on September 2018

Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis


Brief description of study

The purpose of this study is to determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

Detailed Study Description

The drug being tested in this study is called IXAZOMIB. IXAZOMIB was being tested to treat people who have relapsed or Refractory Systemic Light Chain (AL) Amyloidosis.

The study will enroll approximately 248 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

  • IXAZOMIB 4 mg plus Dexamethasone 20 mg
  • Physician's choice: Participants will receive one of the following treatment options as selected by the physician:
    1. Dexamethasone 20 mg
    2. Dexamethasone 20 mg + Melphalan 0.22 mg/kg
    3. Dexamethasone 20 mg + Cyclophosphamide 500 mg
    4. Dexamethasone 20 mg + Thalidomide 200 mg
    5. Dexamethasone 20 mg + Lenalidomide 15 mg
    6. All participants will be asked to take oral formulation of the drugs. In both treatment arms, each participant will continue to receive sequential cycles of therapy until disease progression, unacceptable toxicity, or until the study is terminated, whichever occurs first. Participants in Arm B receiving melphalan and dexamethasone will be treated to best response plus 2 additional cycles.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 112 months (9.3 years), including 84 months of enrollment and 28 months of follow-up after the last participant is enrolled.

Clinical Study Identifier: NCT01659658

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Cedars Sinai Medical Center
Los Angeles, CA United States
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University of Chicago
Chicago, IL United States
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Indiana University School of Medicine
Indianapolis, IN United States
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Boston Medical Center
Boston, MA United States
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Tufts Medical Center
Boston, MA United States
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Karmanos Cancer Institute
Detroit, MI United States
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Mayo Clinic
Rochester, MN United States
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Washington University
Saint Louis, MO United States
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Columbia University Medical Center
New York, NY United States
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Memorial Sloan Kettering Cancer Center
New York, NY United States
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University of Cincinnati
Cincinnati, OH United States
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Cleveland Clinic
Cleveland, OH United States
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Vanderbilt University Medical Center
Nashville, TN United States
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University of Texas Southwestern Medical Center
Dallas, TX United States
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Froedtert and The Medical College of Wisconsin
Milwaukee, WI United States
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Westmead Hospital
Westmead, Australia
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Princess Alexandra Hospital
Woolloongabba, Australia
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Box Hill Hospital
Box Hill, Australia
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Sir Charles Gairdner Hospital
Nedlands, Australia
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Centro de Pesquisas Oncologicas
Florianopolis, Brazil
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Hospital Universitario Clementino Fraga Filho (UFRJ)
Rio de Janeiro, Brazil
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Irmandade Da Santa Casa de Misericordia de Sao Paulo
Sao Paulo, Brazil
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Hospital Israelita Albert Einstein
Sao Paulo, Brazil
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Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil
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Tom Baker Cancer Centre
Calgary, AB Canada
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Cross Cancer Institute
Edmonton, AB Canada
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Vancouver General Hospital
Vancouver, BC Canada
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Princess Margaret Hospital
Toronto, ON Canada
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Fakultni nemocnice Ostrava
Ostrava, Czechia
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Vseobecna fakultni nemocnice v Praze
Praha, Czechia
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Arhus Universitetshospital Arhus Sygehus
Aahus, Denmark
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Rigshospitalet
Copenhagen, Denmark
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Hopital Claude Huriez
Lille, France
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Centre Hospitalier et Universitaire de Limoges
Limoges, France
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Hopital Saint Louis
Paris, France
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Hopital de Rangueil
Toulouse, France
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Charite - Universitatsmedizin Berlin
Berlin, Germany
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Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany
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Universitat Heidelberg
Heidelberg, Germany
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University General Hospital of Patras
Patras, Greece
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Alexandra Hospital
Athens, Greece
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Rambam Health Corporation
Haifa, Israel
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Hadasit Medical Research Services and Development Ltd
Jerusalem, Israel
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Meir Medical Center
Kfar Saba, Israel
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Rabin Medical Center - PPDS
Petach Tikva, Israel
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Chaim Sheba Medical Center
Ramat-Gan, Israel
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Institute of Hematology "Seragnoli" University of Bologna
Bologna, Italy
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Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Italy
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Gachon University Gil Medical Center
Incheon, Korea, Republic of
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Seoul National University Hospital
Seoul, Korea, Republic of
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Severance Hospital at Yonsei University Health System - PPDS
Seoul, Korea, Republic of
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Samsung Medical Center - PPDS
Seoul, Korea, Republic of
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The Catholic University of Korea, Seoul St Mary's Hospital
Seoul, Korea, Republic of
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VU Medisch Centrum
Amsterdam, Netherlands
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Maastricht University Medical Center
AZ Maastricht, Netherlands
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Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
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Clinica Universidad de Navarra
Pamplona, Spain
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Hospital Clinic de Barcelona
Barcelona, Spain
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Madrid, Spain
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Majadahonda, Spain
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Salamanca, Spain
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Queen Elizabeth Hospital
Birmingham, United Kingdom
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Royal Free and University College Medical School
London, United Kingdom
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Manchester Royal Infirmary
Manchester, United Kingdom
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Oxford University Hospitals NHS Trust
Oxford, United Kingdom
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