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
- Multiple Myeloma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 1,000
- Started
- 9 September 2026
- Main results due
- 4 September 2030
- Study sites
- 19
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion criteria: * 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; or iii. deferral of high-dose chemotherapy with ASCT as initial treatment * 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 Exclusion criteria: * 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 * Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients * Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(19)
Rambam Med.Center - Hematology Institute
Haifa, Israel
Recruiting
Carmel Medical Center
Haifa, Israel
Recruiting
Shaare Zedek Medical Center
Jerusalem, Israel
Recruiting
Rabin Medical Center
Petah Tikva, Israel
Recruiting
Sheba Medical Center
Ramat Gan, Israel
Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Recruiting
The Catholic University of Korea Eunpyeong St Marys Hospital
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea
Recruiting
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, Turkey (Türkiye)
Recruiting
Liv Hospital Ankara
Ankara, Turkey (Türkiye)
Recruiting
Medipol Mega University Hospital
Istanbul, Turkey (Türkiye)
Recruiting
Istanbul Florence Nightingale Hastanesi
Istanbul, Turkey (Türkiye)
Recruiting
Izmir Tinaztepe Universitesi Ozel Galen Hastanesi
Izmir, Turkey (Türkiye)
Recruiting
Ondokuz Mayis University
Samsun, Turkey (Türkiye)
Recruiting
Blackpool Victoria Hospital
Blackpool, United Kingdom
Recruiting
Addenbrooke's Hospital
Cambridge, United Kingdom
Recruiting
Kent and Canterbury Hospital
Canterbury, United Kingdom
Recruiting
Showing 19 of 19 sites. 19 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07665450. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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