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A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
Sponsor: Janssen Research & Development, LLC
Summary
The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \[WBCs\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.
Official title: A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma 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
1000
Start Date
2026-09-09
Completion Date
2035-02-02
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Ramantamig
Ramantamig will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Lenalidomide
Lenalidomide will be administered orally.
Bortezomib
Bortezomib will be administered subcutaneously or intravenously.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
Locations (103)
St Vincent s Hospital Sydney
Darlinghurst, Australia
Mater Hospital Brisbane
South Brisbane, Australia
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Plzen
Pilsen, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Hopital Claude Huriez
Lille, France
CHU de Montpellier Hopital Saint Eloi
Montpellier, France
CHU Nantes
Nantes, France
Aphp Hopital Saint Antoine
Paris, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, France
CHU Lyon Sud
Pierre-Bénite, France
IUCT Oncopole Institut Claudius Regaud
Toulouse, France
CHRU Tours Hopital Bretonneau
Tours, France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, France
St. Barbara-Klinik Hamm GmbH
Hamm, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Germany
Uni General Hospital of Alexandroupolis
Alexandroupoli, Greece
Evangelismos S A
Athens, Greece
Laiko General Hospital of Athens
Athens, Greece
Alexandra General Hospital of Athens
Athens, Greece
Theageneio Cancer Hospital
Thessaloniki, Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou
Thessaloniki, Greece
Rambam Med.Center - Hematology Institute
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
A O U Sant Orsola Malpighi
Bologna, Italy
S.C. Ematologia Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Catharina Ziekenhuis
Eindhoven, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Zuyderland Medical Center
Sittard-Geleen, Netherlands
UMCU
Utrecht, Netherlands
Jan Biziel's University Hospital
Bydgoszcz, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, Poland
Uniwersyteckie Centrum Kliniczne Uniwersytet Medyczny
Gdansk, Poland
Pratia Onkologia Katowice
Katowice, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, Poland
Pratia MCM Krakow
Krakow, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Lublin, Poland
Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
Szczecin, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Poland
Uls Braga - Hosp. Braga
Braga, Portugal
Fund. Champalimaud
Lisbon, Portugal
Ipo Porto
Porto, Portugal
Ulstmad - Hosp. Sao Pedro de Vila Real
Vila Real, Portugal
National Cancer Center
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea Eunpyeong St Marys Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain
Hosp.Clinic and Provincial
Barcelona, Spain
Hosp. San Pedro de Alcantara
Cáceres, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain
Hosp. de Leon
León, Spain
Hosp. Univ. Lucus Augusti
Lugo, Spain
Hosp. Univ. de La Princesa
Madrid, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. Infanta Leonor
Madrid, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Univ. La Paz
Madrid, Spain
Complejo Hosp. de Navarra 1
Pamplona, Spain
Complejo Hosp. de Navarra
Pamplona, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
Hospital Universitario Virgen Rocio
Seville, Spain
Hosp. Univ. Dr. Peset
Valencia, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, Spain
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, Turkey (Türkiye)
Memorial Antalya Hastanesi
Antalya, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, Turkey (Türkiye)
Koc Universitesi Hastanesi
Istanbul, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, Turkey (Türkiye)
Istanbul Florence Nightingale Hastanesi
Istanbul, Turkey (Türkiye)
Izmir Tinaztepe Universitesi Ozel Galen Hastanesi
Izmir, Turkey (Türkiye)
Ondokuz Mayis University
Samsun, Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Bristol NHS Foundation Trust
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
Colchester Hospital University NHS
Colchester, United Kingdom