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Clinical Trials (PDQ®)

A Phase 3 Study Comparing Oral IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / IndustryC16010
2011-005496-17, CTR20130908, NCT01564537

Trial Description

Summary

The purpose of this phase 3, randomized, double-blind, multicenter study is to compare Oral IXAZOMIB plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.

Eligibility Criteria

Inclusion Criteria:

  • Male or female patients 18 years or older
  • Diagnosed Multiple Myeloma according to standard criteria
  • Measurable disease as specified in study protocol
  • Eastern Cooperative Oncology Group (ECOG)performance status of 0 to 2
  • Patients with relapsed and/or refractory Multiple Myeloma who have received 1 to 3 prior therapies
  • Meet the clinical laboratories criteria as specified in the protocol
  • Patients who received prior allogenic transplant must have no active graft-versus-host disease (GVHD)
  • Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse; must also adhere to the guidelines of the lenalidomide pregnancy prevention program
  • Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse AND must adhere to the guidelines of the lenalidomide pregnancy prevention program
  • Must be able to take concurrent aspirin 325 mg daily
  • Voluntary written consent

Exclusion Criteria:

  • Patient who were refractory to lenalidomide or proteasome inhibitor-based therapy
  • Female patients who are lactating or pregnant
  • Major surgery or radiotherapy within 14 days before randomization
  • Infection requiring systematic antibiotics within 14 days before the first dose of study drug
  • Central nervous system involvement
  • Failure to have fully recovered from the effects of prior chemotherapy regardless of the interval since last treatment
  • Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginko biloba or St. John's wort within 14 days before the first dose of study treatment
  • Diagnosis of Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
  • Evidence of current uncontrolled cardiovascular conditions
  • Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
  • Known allergy to any of the study medications
  • Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of IXAZOMIB - Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ
  • Ongoing or active systemic infection, active hepatitis B virus infect, active hepatitis C infection, or known human immunodeficiency virus (HIV) positive

Trial Contact Information

Trial Lead Organizations/Sponsors

Millennium Pharmaceuticals, Incorporated

Medical MonitorStudy Director

For an updated listing of recruitment sites contact: Millennium Medical and Drug Information CenterPh: 1-877-674-3784
  Email: medical@mlnm.com

Trial Sites

U.S.A.
California
  Anaheim
 Pacific Cancer Medical Center, Incorporated
  San Pablo
 Alta Bates Comprehensive Cancer Center
Florida
  Gainesville
 UF Health Cancer Center
  Lecanto
 Cancer and Blood Disease Center
Georgia
  Marietta
 Northwest Georgia Oncology Centers, PC - Marietta Center
Illinois
  Chicago
 John H. Stroger Jr. Hospital of Cook County
Massachusetts
  Boston
 Beth Israel Deaconess Medical Center
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Massachusetts General Hospital
Minnesota
  Rochester
 Mayo Clinic Cancer Center
New York
  Buffalo
 Roswell Park Cancer Institute
Pennsylvania
  Scranton
 Scranton Hematology Oncology
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
Tennessee
  Nashville
 Vanderbilt-Ingram Cancer Center
Washington
  Seattle
 Fred Hutchinson Cancer Research Center
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Wisconsin
  Milwaukee
 Medical College of Wisconsin Cancer Center
Australia
  Heidleberg, VIC
 Austin Hospital
  Melbourne, VIC
 The Alfred Hospital
  Woolloongabba
 Princess Alexandra Hospital
New South Wales
  Camperdown
 Sydney Cancer Centre at Royal Prince Alfred Hospital
Austria
  Graz
 Landeskrankenhaus/Universitatskliniken Graz
  Salzburg
 Salzburger Landeskliniken
  Wels
 Klinikum Kreuzschwestern Wels GmbH
Belgium
  Andtwerpen
 ZNA AZ Stuivenberg
  Brussels
 Academisch Ziekenhuis der Vrije Universiteit Brussel
 Cliniques Universitaires Saint-Luc
  Mons
 Centre Hospitalier Universitaire Ambroise Pare - Mons
  Roeselare
 H.-Hartziekenhuis Roeselare-Menen
  Yvoir
 Clinique Universitaire De Mont-Godinne
Canada
  Saint John
 Saint John Regional Hospital
  St. John's, NL
 General Hospital
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
  Edmonton
 Cross Cancer Institute at University of Alberta
British Columbia
  Vancouver
 Vancouver General Hospital
Quebec
  Montreal
 Royal Victoria Hospital - Montreal
Czech Republic
  Brno
 Faculty Hospital Brno
 Fakultni nemocnice Ostrava
  Hradec Kralove
 Fakultni Nemocnice Hradec Kralove
  Olomouc
 University Hospital - Olomouc
  Praha 10
 Fakultni Nemocnice Kralovske Vinohrady
Denmark
  Aalborg
 Aalborg Sygehus
  Aarhus C
 Aarhus Universitetshospital - Aarhus Sygehus
  Kobenhavn O
 Rigshospitalet
France
  Lille Cedex
 Hôpital Claude Huriez
  Limoges Cedex
 Hopital Universitaire Dupuytren
  Marseille Cedex
 Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  Montpellier cedex 5
 Hôpital Saint Eloi
  Nantes
 CHR Hotel Dieu
  Paris
 Hopital Saint Antoine
 Hopital Saint-Louis
  Pessac
 Hopital Haut Leveque
  Rennes cedex 9
 Centre Hospitalier Universitaire de Rennes
  Toulouse
 Centre Hospitalier Regional de Purpan
  Tours cedex
 Centre Hospitalier Universitaire Bretonneau de Tours
Germany
  Berlin
 Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  Düsseldorf
 Universitaetsklinikum Duesseldorf
  Hamburg
 Allgemeines Krankenhaus Altona
  Munchen
 Hämatologische / Onkologische Praxisgemeinschaft
  Ulm
 Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Hungary
  Budapest
 Egyesitett Szent Istvan es Szent Laszlo Korhaz
  Debrecen
 Debreceni Egyetem Orvos- és Egészségtudományi Cent
  Gyula
 Pándy Kálmán Megyei Kórház
Israel
  Haifa
 Rambam Medical Center
  Jerusalem
 Hadassah University Hospital
  Kfar Saba
 Meir Hospital
  Nahariya
 Western Galilee Hospital Nahariya
  Petach Tikva
 Rabin Medical Center - Beilinson Campus
  Rehovot
 Kaplan Hospital
  Tel Aviv
 Tel-Aviv Sourasky Medical Center
Italy
  Bologna
 Azienda Ospedaliero-Universitaria di Bologna - Pol
  Firenze
 Azienda Ospedaliero Careggi
  Meldola
 IRST- Istituto Scientifico Romagnolo per
  Naples
 AORN
  Parma
 Azienda Ospedaliera Di Parma
  Rome
 Ospedale S. Eugenio
  Terni
 Azienda Ospedaliera S. Maria
  Turin
 A.S.O. Molinette S. Giovanni Battista
Netherlands
  Amsterdam
 Academisch Medisch Centrum at University of Amsterdam
 Vrije Universiteit Medisch Centrum
  Groningen
 University Medical Center Groningen
  Maastricht
 Academisch Ziekenhuis Maastricht
  Rotterdam
 Erasmus MC (Central Location)
  Utrecht
 University Medical Center Utrecht
New Zealand
  Auckland
 Middlemore Hospital
  Christchurch
 Canterbury Health Laboratories
  Grafton Auckland
 Auckland City Hospital
  Hamilton
 Waikato Hospital
  Palmerston North
 Palmerston North Hospital
  Wellington
 Wellington Regional Hospital
Poland
  Chorzow
 Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  Gdansk
 Universitätsklinikum Ulm
  Lodz
 Wojewodzki Szpital Specjalistyczny im. M. Kopernik
  Lublin
 Samodzielny Publiczny Szpital Kliniczny Nr 1
Portugal
  Braga
 Hospital de Braga
  Coimbra
 Centro Hospitalar e Universitário de Coimbra, EPE
  Porto
 Instituto Portugues de Oncologia do Porto Francisc
Republic of Singapore
  Singapore
 Cancer Institute at National University Hospital
 Singapore General Hospital
Romania
  Brasov
 Emergency County Clinical Hospital Brasov
  Bucharest
 "Coltea" Clinical Hospital
 Emergency University Hospital
Spain
  Barcelona
 Hospital Clinic de Barcelona
 Hospital de la Santa Cruz i Sant Pau
  Madrid
 Hospital General Universitario Gregorio Maranon
  Marbella
 Hospital Costa del Sol
  Salamanca
 University Hospital - Salamanca
  San Sebastian
 Hospital Donostia
Sweden
  Goteborg
 Sahlgrenska Universitetssjukhuset
  Lund
 Skånes Universitetssjukhus- Lund
  Stockholm
 Karolinska Universitetssjukhuset i Huddinge
 Karolinska universitetssjukhuset Solna
Turkey
  Ankara
 Ankara University Medical Faculty Cebeci Hospital
 Gazi University Hospital
  Kayseri
 Erciyes University Medical Faculty
United Kingdom
  Aberdeen
 Aberdeen Royal Infirmary
  Birmingham
 Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
  Dundee
 Ninewells Hospital
  Manchester
 Christie Hospital
  Southampton
 Southampton General Hospital
  Wolverhampton
 The Royal Wolverhampton Hospitals NHS Trust

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01564537
ClinicalTrials.gov processed this data on June 09, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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