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A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
Official title: A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
395
Start Date
2018-11-06
Completion Date
2026-04-30
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (114)
Innovative Clinical Research Inc
Cerritos, California, United States
Baptist MD Anderson
Jacksonville, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States
Norton Healthcare
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan, United States
Saint Lukes Hospital Saint Lukes Cancer Specialists
Kansas City, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Winthrop
Mineola, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Good Samaritan Hospital Corvallis
Corvallis, Oregon, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Gibbs Cancer Center
Spartanburg, South Carolina, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Universidade Estadual De Campinas
Campinas, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, Brazil
Instituto de Ensino e Pesquisa São Lucas
São Paulo, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, Brazil
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia
São Paulo, Brazil
Hospital Santa Cruz
São Paulo, Brazil
Clinica Medica Sao Germano S/S LTDA
São Paulo, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
The Gordon & Leslie Diamond Health Care Center
Vancouver, British Columbia, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Brampton Civic Hospital
Brampton, Ontario, Canada
Victoria Hospital
London, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec, Canada
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Pilsen, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
CHU Henri Mondor
Créteil, France
Centre Hospitalier Départmental La Roche sur Yon
La Roche-sur-Yon, France
Hopital Claude Huriez
Lille, France
Institut Paoli Calmettes
Marseille, France
CHU de Montpellier Hopital Saint Eloi
Montpellier, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, France
Strasbourg Oncologie Libérale
Strasbourg, France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, France
phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg
Aschaffenburg, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, Germany
St. Josef-Krankenhaus Hamm-Bockum-Hövel
Hamm, Germany
Institut für Versorgungsforschung
Koblenz, Germany
Universitatsmedizin Leipzig
Leipzig, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität
München, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, Germany
Barzilai Medical Center
Ashkelon, Israel
Hillel Yaffe Medical Center
Hadera, Israel
Rambam Med.Center - Hematology Institute
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Meir Hospital
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Sourasky (Ichilov) Medical Center
Tel Aviv, Israel
Fukuoka University Hospital
Fukuoka, Japan
Ogaki Municipal Hospital
Gifu, Japan
Kanazawa University Hospital
Kanazawa, Japan
Kobe City Medical Center General Hospital
Kobe, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, Japan
Matsuyama Red Cross Hospital
Matsuyama, Japan
Nagoya City University Hospital
Nagoya, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Japanese Red Cross Osaka Hospital
Osaka, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, Japan
Japanese Red Cross Medical Center
Shibuya City, Japan
VU Medisch Centrum
Amsterdam, Netherlands
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht, Netherlands
Erasmus MC
Rotterdam, Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, Poland
NSSU Szpital Uniwersytecki w Krakowie
Krakow, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
Słupsk, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Hosp. Univ. Fundacion Alcorcon
Alcorcón, Spain
Hosp. Del Mar
Barcelona, Spain
Hosp. Univ. de Guadalajara
Guadalajara, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, Spain
Hosp. Mutua Terrassa
Terrassa, Spain
Gulhane Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
Ankara University School of Medicine Cebeci Hospital
Ankara, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, Turkey (Türkiye)
On Dokuz Mayis Universitesi Tip Fakultesi
Samsun, Turkey (Türkiye)
Monklands District General Hospital
Airdrie, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
University Hospital Wales
Cardiff, United Kingdom
Colchester Hospital University NHS
Colchester, United Kingdom
Leicester Royal Infirmary - Haematology
Leicester, United Kingdom
Altnagelvin Hospital
Londonderry, United Kingdom
The Royal Oldham Hospital
Oldham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom