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NCT07665450RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
18 Jun 2026
Start date
9 Sept 2026
Primary completion date
4 Sept 2030
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT07665450

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1000
  • From 9 Sept 2026 to the primary completion date, 4 Sept 2030
  • 103 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose of trial intervention or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the trial
  • Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM
  • Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of emergency use of a short course of corticosteroids

Other illness

  • Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients

Age

  • Myeloma Frailty Score of greater than or equal to (\>=) 2 with the exception of participants who have a score of 2 based on age alone

Who the study is looking for

  • Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria
  • Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT
  • Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2
  • Must sign an informed consent form (ICF)
  • Measurable disease at screening as assessed by central laboratory as defined in the protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (103)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Vincent's Hospital Sydney
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DarlinghurstAustraliaRecruiting
Mater Hospital Brisbane
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South BrisbaneAustraliaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Fakultni nemocnice Plzen
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PilsenCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaRecruiting
St. Barbara-Klinik Hamm GmbH
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HammGermanyRecruiting
Universitaetsklinikum Wuerzburg
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WürzburgGermanyRecruiting
Hosp. Univ. Germans Trias I Pujol
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BadalonaSpainRecruiting
Hosp. de La Santa Creu I Sant Pau
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BarcelonaSpainRecruiting
Hosp.Clinic and Provincial
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BarcelonaSpainRecruiting
Hosp. San Pedro de Alcantara
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CáceresSpainRecruiting
Hosp. Univ. Virgen de Las Nieves
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GranadaSpainRecruiting
Hosp. de Jerez de La Frontera
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Jerez de la FronteraSpainRecruiting
Hosp. de Leon
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LeónSpainRecruiting
Hosp. Univ. Lucus Augusti
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LugoSpainRecruiting
Hosp. Univ. de La Princesa
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MadridSpainRecruiting
Hosp. Univ. Infanta Leonor
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MadridSpainRecruiting
Hosp. Gral. Univ. Gregorio Maranon
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MadridSpainRecruiting
Hosp. Univ. La Paz
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MadridSpainRecruiting
Hosp. Univ. Ramon Y Cajal
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MadridSpainRecruiting
Hosp. Univ. 12 de Octubre
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MadridSpainRecruiting
Complejo Hosp. de Navarra
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PamplonaSpainRecruiting
Complejo Hosp. de Navarra 1
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PamplonaSpainRecruiting
Hosp. Quiron Madrid Pozuelo
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Pozuelo de AlarcónSpainRecruiting
Hosp Clinico Univ de Salamanca
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SalamancaSpainRecruiting
Hosp. Univ. Marques de Valdecilla
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SantanderSpainRecruiting
Hospital Universitario Virgen Rocio
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SevilleSpainRecruiting
Hosp. Univ. Dr. Peset
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ValenciaSpainRecruiting
Hosp. Clinico Univ. Lozano Blesa
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ZaragozaSpainRecruiting
Hopital Claude Huriez
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LilleFranceRecruiting
CHU de Montpellier Hôpital Saint Eloi
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MontpellierFranceRecruiting
CHU Nantes
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NantesFranceRecruiting
APHP - Hôpital Saint Antoine
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ParisFranceRecruiting
CHU de Bordeaux - Hospital Haut-Leveque
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PessacFranceRecruiting
CHU Lyon Sud
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Pierre-BéniteFranceRecruiting
IUCT Oncopole - Institut Claudius Regaud
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ToulouseFranceRecruiting
CHRU Tours Hopital Bretonneau
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ToursFranceRecruiting
CHU Nancy-Brabois
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Vandœuvre-lès-NancyFranceRecruiting
University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomRecruiting
Blackpool Victoria Hospital
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BlackpoolUnited KingdomRecruiting
Bristol NHS Foundation Trust
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BristolUnited KingdomRecruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
Kent and Canterbury Hospital
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CanterburyUnited KingdomRecruiting
Colchester Hospital University NHS
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ColchesterUnited KingdomRecruiting
Western General Hospital
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EdinburghUnited KingdomRecruiting
New Cross Hospital
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Heath TownUnited KingdomRecruiting
University College Hospital
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LondonUnited KingdomRecruiting
Uni General Hospital of Alexandroupolis
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AlexandroupoliGreeceRecruiting
Alexandra General Hospital of Athens
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AthensGreeceRecruiting
Evangelismos S A
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AthensGreeceRecruiting
Laiko General Hospital of Athens
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AthensGreeceRecruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceRecruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceRecruiting
Carmel Medical Center
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HaifaIsraelRecruiting
Rambam Med.Center - Hematology Institute
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HaifaIsraelRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
A O U Sant Orsola Malpighi
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BolognaItalyRecruiting
S.C. Ematologia Azienda Ospedaliera S. Croce e Carle
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CuneoItalyRecruiting
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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MilanItalyRecruiting
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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PalermoItalyRecruiting
National Cancer Center
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Gyeonggi-doSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Gyeonggi-doSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaRecruiting
The Catholic University of Korea Eunpyeong St Marys Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Ulsan University Hospital
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UlsanSouth KoreaRecruiting
Catharina Ziekenhuis
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EindhovenNetherlandsRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Sint Antonius Ziekenhuis
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NieuwegeinNetherlandsRecruiting
Zuyderland Medical Center
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Sittard-GeleenNetherlandsRecruiting
UMCU
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UtrechtNetherlandsRecruiting
Jan Biziel's University Hospital
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BydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
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ChorzówPolandRecruiting
Uniwersyteckie Centrum Kliniczne Uniwersytet Medyczny
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GdanskPolandRecruiting
Pratia Onkologia Katowice
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KatowicePolandRecruiting
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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KielcePolandRecruiting
Pratia MCM Krakow
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KrakowPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
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SzczecinPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
Uls Braga - Hosp. Braga
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BragaPortugalRecruiting
Fund. Champalimaud
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LisbonPortugalRecruiting
IPO Porto
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PortoPortugalRecruiting
Ulstmad - Hosp. Sao Pedro de Vila Real
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Vila RealPortugalRecruiting
Liv Hospital Ankara
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AnkaraTurkey (Türkiye)Recruiting
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
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AnkaraTurkey (Türkiye)Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
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AnkaraTurkey (Türkiye)Recruiting
Akdeniz Universitesi Tip Fakultesi
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AntalyaTurkey (Türkiye)Recruiting
Memorial Antalya Hastanesi
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AntalyaTurkey (Türkiye)Recruiting
Medipol Mega University Hospital
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IstanbulTurkey (Türkiye)Recruiting
Istanbul Florence Nightingale Hastanesi
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IstanbulTurkey (Türkiye)Recruiting
Koc Universitesi Hastanesi
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IstanbulTurkey (Türkiye)Recruiting
Izmir Tinaztepe Universitesi Ozel Galen Hastanesi
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IzmirTurkey (Türkiye)Recruiting
Ondokuz Mayis University
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SamsunTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.