395
Participants
Start Date
November 6, 2018
Primary Completion Date
May 7, 2024
Study Completion Date
January 9, 2026
Daratumumab
Daratumumab (1800 mg) will be administered by SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3-8. For Cycle 9 and beyond, participants will receive daratumumab 1800 mg SC once every 4 weeks until documented disease progression or unacceptable toxicity.
Bortezomib
Bortezomib 1.3 mg/m\^2 will be administered by SC injection twice weekly on Days 1, 4, 8, and 11 of each 21-day cycle for Cycles 1-8.
Lenalidomide
Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 and beyond until disease progression or unacceptable toxicity whichever occurs first.
Dexamethasone
Dexamethasone will be self-administered orally, 20 mg on Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day cycle for Cycles 1-8. During Cycle 9 and beyond dexamethasone, will be self-administered orally at a total dose of 40 mg on Days 1, 8, 15, 22 of each 28-day cycle.
Universitatsmedizin Leipzig, Leipzig
NYU Winthrop, Mineola
Institut Paoli Calmettes, Marseille
Roswell Park Cancer Institute, Buffalo
Hosp. Univ. de Guadalajara, Guadalajara
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli, Lublin
University of Virginia, Charlottesville
Levine Cancer Institute, Charlotte
Hosp. Univ. Pta. de Hierro Majadahonda, Majadahonda
Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcón
Hosp. Univ. Fundacion Alcorcon, Alcorcón
Gibbs Cancer Center, Spartanburg
Institut Universitaire du cancer de Toulouse-Oncopole, Toulouse
Baptist MD Anderson, Jacksonville
CHU de Bordeaux - Hospital Haut-Leveque, Pessac
Istanbul University Istanbul Medical Faculty, Istanbul
CHU de Montpellier Hopital Saint Eloi, Montpellier
Dokuz Eylul University Medical Faculty, Izmir
Hillel Yaffe Medical Center, Hadera
Norton Healthcare, Louisville
Cleveland Clinic, Cleveland
Meir Hospital, Kfar Saba
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne
Rabin Medical Center, Petah Tikva
Cancer And Hematology Centers of Western Michigan PC, Grand Rapids
Sheba Medical Center, Ramat Gan
Ondokuz Mayis University, Samsun
Institut für Versorgungsforschung, Koblenz
Hopital Claude Huriez, Lille
St. Josef-Krankenhaus Hamm-Bockum-Hövel, Hamm
phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg, Aschaffenburg
Saint Lukes Hospital Saint Lukes Cancer Specialists, Kansas City
Sourasky (Ichilov) Medical Center, Tel Aviv
Strasbourg Oncologie Libérale, Strasbourg
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,, Tübingen
University of Texas, MD Anderson Cancer Center, Houston
Barzilai Medical Center, Ashkelon
Universitatsklinikum Freiburg, Freiburg im Breisgau
Klinikum Großhadern der Ludwig-Maximilians-Universität, München
Centre Hospitalier Départmental La Roche sur Yon, La Roche-sur-Yon
San Juan Oncology Associates, Farmington
Innovative Clinical Research Inc, Cerritos
CHU Henri Mondor, Créteil
Good Samaritan Hospital Corvallis, Corvallis
Rambam Med.Center - Hematology Institute, Haifa
Carmel Medical Center, Haifa
Tufts Medical Center, Boston
Boston University Medical Center, Boston
Rutgers Cancer Institute of New Jersey, New Brunswick
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center, Pittsburgh
Universidade Estadual De Campinas, Campinas
Liga Norte Riograndense Contra O Cancer, Natal
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre
Ministerio da Saude Instituto Nacional do Cancer, Rio de Janeiro
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro
Instituto de Ensino e Pesquisa São Lucas, São Paulo
Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia, São Paulo
Hospital Santa Cruz, São Paulo
Clinica Medica Sao Germano S/S LTDA, São Paulo
Arthur J E Child Comprehensive Cancer Centre, Calgary
Cross Cancer Institute, Edmonton
The Gordon & Leslie Diamond Health Care Center, Vancouver
QEII Health Sciences Centre, Halifax
Brampton Civic Hospital, Brampton
Victoria Hospital, London
Lakeridge Health Oshawa, Oshawa
McGill University Health Centre, Montreal
CHU de Quebec L Hotel Dieu de Quebec, Québec
Fakultni nemocnice Brno, Brno
Fakultni nemocnice Hradec Kralove, Hradec Králové
Fakultni Nemocnice Ostrava, Ostrava
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni, Pilsen
Vseobecna fakultni nemocnice v Praze, Prague
Fukuoka University Hospital, Fukuoka
Ogaki Municipal Hospital, Gifu
Kanazawa University Hospital, Kanazawa
Kobe City Medical Center General Hospital, Kobe
National Hospital Organization Kumamoto Medical Center, Kumamoto
University Hospital Kyoto Prefectural University of Medicine, Kyoto
National Hospital Organization Matsumoto Medical Center, Matsumoto
Matsuyama Red Cross Hospital, Matsuyama
Nagoya City University Hospital, Nagoya
National Hospital Organization Okayama Medical Center, Okayama
Japanese Red Cross Osaka Hospital, Osaka
National Hospital Organization Shibukawa Medical Center, Shibukawa
Japanese Red Cross Medical Center, Shibuya City
VU Medisch Centrum, Amsterdam
Albert Schweitzer ziekenhuis-lokatie Dordwijk, Dordrecht
Erasmus MC, Rotterdam
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza, Brzozów
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzów
Uniwersyteckie Centrum Kliniczne, Gdansk
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce
NSSU Szpital Uniwersytecki w Krakowie, Krakow
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, Słupsk
Instytut Hematologii i Transfuzjologii, Warsaw
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warsaw
Hosp. Del Mar, Barcelona
Hosp. Mutua Terrassa, Terrassa
Gulhane Egitim ve Arastirma Hastanesi, Ankara
Hacettepe University Medical Faculty, Ankara
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara
Ankara University School of Medicine Cebeci Hospital, Ankara
Monklands District General Hospital, Airdrie
Blackpool Victoria Hospital, Blackpool
University Hospital Wales, Cardiff
Colchester Hospital University NHS, Colchester
Leicester Royal Infirmary - Haematology, Leicester
Altnagelvin Hospital, Londonderry
The Royal Oldham Hospital, Oldham
Derriford Hospital, Plymouth
New Cross Hospital, Wolverhampton
Janssen Research & Development, LLC
INDUSTRY