Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Amyloidosis

Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments for patients with Relapsed or Refractory Systemic Light Chain Amyloidosis

Research Study Title

A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physician's Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Purpose

This is a phase 3, randomized, controlled, open-label, multicenter study of the oral formulation of dexamethasone plus IXAZOMIB compared with treatment chosen by the investigator from a prespecified list of regimens available in clinical practice. Treatment options will include: dexamethasone alone, dexamethasone plus an alkylating agent (melphalan or cyclophosphamide), or dexamethasone plus an immunomodulatory drug (IMiD, thalidomide or lenalidomide) in patients with relapsed or refractory AL amyloidosis. Crossover to the investigational treatment arm is not permitted during participation in this study.

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Millennium Pharmaceuticals, Inc.

Duration

65 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Male or female patients 18 years or older

  • Biopsy-proven AL amyloidosis with relapsed or refractory disease despite 1 or 2 prior therapies. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy

  • Disease requiring further treatment

  • Measurable disease as defined by serum differential free light chain concentration (dFLC)

  • Objective and measurable major organ involvement (ie, cardiac or renal) as defined by the standard International Society of Amyloidosis (ISA) criteria.

  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2

  • Meet the clinical laboratories criteria as specified in the protocol

  • Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception through 90 days after the last dose of study treatment or agree to practice true abstinence; must also adhere to the guidelines of any treatment specific pregnancy prevention program

  • Male patients who agree to practice effective barrier contraception through 90 days after the last dose of study treatment or agree to practice true abstinence AND must adhere to the guidelines of any treatment specific pregnancy prevention program

  • Voluntary written consent

Exclusion Criteria:

  • Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis

  • Female patients who are lactating, breastfeeding or pregnant

  • Evidence of current uncontrolled cardiovascular conditions as specified in study protocol

  • Clinically overt multiple myeloma as specified in study protocol

  • Inability to swallow medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment

  • Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered to be investigational or which would be considered as a treatment of AL amyloidosis. However, patients may be on chronic steroids (maximum dose 20 mg/day prednisone or equivalent if they are being given for disorders other than amyloidosis

  • Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

  • Ongoing or active infection, known HIV positive, active hepatitis B or C infection

  • Psychiatric illness/social situations that would limit compliance with study requirements

  • Known allergy to any of the study medications, their analogues or excipients

  • Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment

  • Diagnosed or treated for another malignancy within 5 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection

Site Locations (48)

Country State City Zip Facility and Contact
United States Arizona Scottsdale 85359 Mayo Clinic Arizona
Reeder
United States California Los Angeles 90048-18 Cedars-Sinai Medical Center
Lill
United States Florida Weston 33331 The Cleveland Clinic
United States Illinois Chicago 60637 University of Chicago
United States Indiana Indianapolis 46202 IU Simon Cancer Center
United States Massachusetts Boston 02118 Boston Medical Center HEM/ONCO
United States Massachusetts Boston 02111 Tufts Medical Center
United States Michigan Detroit 48201 Barbara Ann Karmanos Cancer Institute
United States Minnesota Rochester 55905 Mayo Clinic
Dispenzieri
United States New York New York 10017 Memorial Sloan-Kettering Cancer Center
Heather Landau
United States Pennsylvania Philadelphia 19104 Abramson Cancer Center of Univ of Pennsylvania
United States Tennessee Nashville 37232 Vanderbilt University Medical Center
Goodman
United States Wisconsin Milwaukee 53226 Froedtert & Medical College of Wisconsin
Australia Queensland Woolloongabba QLD 4102 Princess Alexandra Hospital
Australia Camperdown, NSW 2050 Royal Prince Alfred Hospital
Joshua
Australia Nedlands 6009 Sir Charles Gairdner Hospital
Australia Westmead, NSW 2145 Westmead Hospital
Kwok
Canada Alberta Calgary T2N 4N2 Tom Baker Cancer Centre
Canada Ontario Toronto M5G2M9 Princess Margaret Hospital
Kukreti
Canada Vancouver V5Z1M9 Vancouver General Hospital
Denmark Aarhus 8000 Århus University Hospital
Niels Andersen
France Cedex Limoges 87042 CHU Limoges
Jaccard
France Lille 59037 Hopital Huriez, CHRU
Leleu
France Nantes University Hospital Hotel-Dieu Nantes
Philippe Moreau
France Paris 75010 Hospital Saint Louis
Fermand
France Toulouse Cedex 09 31059 CHU Rangueil
Dominique Chauveau
Germany Berlin 12200 Charité Universitätsmedizin Berlin
Germany Heidelberg 69120 University Hospital, Amyloidosis Center Med.
Greece Athens 11528 General Hospital of Athens
Kastritis
Greece Patras 26500 University General Hospital of Patras
Symeonidis
Israel Jerusalem 91120 Hadassah Medical Center - Hadassah University Hosp
Gatt
Israel Kfar Saba 44281 Meir Medical Center
Hardan
Israel Petah-Tiqva 49100 Rabin Medical Center, Beilinson Hospital
Ofer Shpilberg
Italy Bologna 40138 Policlinico S. Orsola-Malpighi
Cavo
Italy Pavia 27100 Centro Amiloidosi Padiglione Forlanini - 3° Piano
Korea, Republic of Incheon 405-760 Gachon University Gil Medical Center
Lee
Korea, Republic of Seoul Seoul National University Hospital
SungSoo Yoon
Korea, Republic of Seoul Seoul St Mary's Hospital
Chang Ki Min
Korea, Republic of Seoul Samsung Medical Center
KiHyun Kim
Netherlands Amsterdam 1018 HV VUMC Ams VUMC Amsterdam
Netherlands Groningen 9731 GZ Groningen Unit for Amyloidosis Research & Develop.
Vellenga
Netherlands Maastricht Maastricht University Medical Centre
Gerard Bos
Netherlands Utrecht 3508 UMC Utrecht
Minnema
Spain Barcelona 08036 Hospital Clinic I Provincial
Blade
Spain Madrid 2800 Hospital Universitario de la Princesa
Alegre
Spain Salamanca 37007 University Hospital of Salamanca
Mateos
United Kingdom Oxon Oxford OX3 7LE Oxford University Hospitals NHS Trust
Ramasamy
United Kingdom London NW3 2PF University College London Medica School
Wechalekar

Contact

For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center
1-877-674-3784

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

NCT ID: NCT01659658

Date Last Changed: June 23, 2014

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.