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
- Diseases
- Multiple myeloma
- 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
Sites (103)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Mater Hospital Brisbane Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Fakultni nemocnice Plzen Coordinator of this site? Confirm its status | Pilsen | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| St. Barbara-Klinik Hamm GmbH Coordinator of this site? Confirm its status | Hamm | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
| Hosp. Univ. Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hosp. de La Santa Creu I Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hosp.Clinic and Provincial Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hosp. San Pedro de Alcantara Coordinator of this site? Confirm its status | Cáceres | Spain | Recruiting |
| Hosp. Univ. Virgen de Las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hosp. de Jerez de La Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Recruiting |
| Hosp. de Leon Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| Hosp. Univ. Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Recruiting |
| Hosp. Univ. de La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp. Univ. Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp. Gral. Univ. Gregorio Maranon Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp. Univ. La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp. Univ. Ramon Y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complejo Hosp. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Complejo Hosp. de Navarra 1 Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hosp. Univ. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Virgen Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hosp. Univ. Dr. Peset Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hosp. Clinico Univ. Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Hopital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU de Montpellier Hôpital Saint Eloi Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| APHP - Hôpital Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU de Bordeaux - Hospital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| CHU Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| IUCT Oncopole - Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHRU Tours Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| CHU Nancy-Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Blackpool Victoria Hospital Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Recruiting |
| Bristol NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Kent and Canterbury Hospital Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Recruiting |
| Colchester Hospital University NHS Coordinator of this site? Confirm its status | Colchester | United Kingdom | Recruiting |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| New Cross Hospital Coordinator of this site? Confirm its status | Heath Town | United Kingdom | Recruiting |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Uni General Hospital of Alexandroupolis Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Recruiting |
| Alexandra General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Rambam Med.Center - Hematology Institute Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| A O U Sant Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| S.C. Ematologia Azienda Ospedaliera S. Croce e Carle Coordinator of this site? Confirm its status | Cuneo | Italy | Recruiting |
| Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Recruiting |
| The Catholic University of Korea Eunpyeong St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Recruiting |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Zuyderland Medical Center Coordinator of this site? Confirm its status | Sittard-Geleen | Netherlands | Recruiting |
| UMCU Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Jan Biziel's University Hospital Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Coordinator of this site? Confirm its status | Chorzów | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Uniwersytet Medyczny Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Pratia Onkologia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Uls Braga - Hosp. Braga Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Fund. Champalimaud Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| IPO Porto Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Ulstmad - Hosp. Sao Pedro de Vila Real Coordinator of this site? Confirm its status | Vila Real | Portugal | Recruiting |
| Liv Hospital Ankara Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Akdeniz Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Recruiting |
| Memorial Antalya Hastanesi Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Recruiting |
| Medipol Mega University Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul Florence Nightingale Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Koc Universitesi Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Izmir Tinaztepe Universitesi Ozel Galen Hastanesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Ondokuz Mayis University Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.