Ramantamig with daratumumab compared with standard treatment for newly diagnosed multiple myeloma
Compares ramantamig plus daratumumab with standard drugs in newly diagnosed multiple myeloma without planned transplant.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Lille, Montpellier, Nantes, Paris, Pessac, Pierre-Bénite, Toulouse, Tours, and Vandœuvre-lès-Nancy, FranceSee the 9 sites
- Phase
- Phase 3
Where in France
- Hopital Claude HuriezLille, FranceTaking people
- CHU de Montpellier Hôpital Saint EloiMontpellier, FranceTaking people
- CHU NantesNantes, FranceTaking people
- APHP - Hôpital Saint AntoineParis, FranceTaking people
- CHU de Bordeaux - Hospital Haut-LevequePessac, FranceTaking people
- CHU Lyon SudPierre-Bénite, FranceTaking people
- IUCT Oncopole - Institut Claudius RegaudToulouse, FranceTaking people
- CHRU Tours Hopital BretonneauTours, FranceTaking people
- CHU Nancy-BraboisVandœuvre-lès-Nancy, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07665450
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients; 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.