A Phase 3 interventional study of Ramantamig and Daratumumab in Multiple Myeloma, sponsored by Janssen Research & Development, LLC. Recruiting at 103 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
Israel, South Korea, Turkey (Türkiye), United Kingdom, France, Greece, Netherlands, Poland, Spain, Australia, Czechia, Germany, Italy, Portugal
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 6, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ramantamig D subcutaneous injection.
Drug: Ramantamig · Drug: Daratumumab
Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.
Drug: Daratumumab · Drug: Lenalidomide · Drug: Bortezomib · Drug: Dexamethasone
Ramantamig will be administered subcutaneously.
Daratumumab will be administered subcutaneously.
Lenalidomide will be administered orally.
Bortezomib will be administered subcutaneously or intravenously.
Dexamethasone will be administered orally or intravenously.
Progression-Free Survival (PFS)
PFS is defined as the duration from randomization to either confirmed progression of disease (PD) or death, whichever occurs first.
Time frame: Up to approximately 62 months
Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
12-month MRD-negative CR rate is defined as participants who achieve MRD-negative status at 12 months (+/-3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, participant must achieve CR or better any time from randomization up to and including 12+3 months prior to PD or subsequent antimyeloma therapy, according to international myeloma working group (IMWG) criteria.
Time frame: Up to 12 months
Overall Survival (OS)
OS is defined as time from treatment assignment (that is, randomization in the trial) to date of death due to any cause.
Time frame: Up to approximately 100 months
Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR
24-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS for at least 24 months without any examination showing MRD positive status or PD in between.
Time frame: Up to 5 years
Percentage of Participants with Very Good Partial Response (VGPR) or Better
Percentage of participants achieving VGPR, CR, or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.
Time frame: Up to 5 years
Percentage of Participants with CR or Better
Percentage of participants achieving CR, or sCR prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.
Time frame: Up to 5 years
Percentage of Participants with Overall Response
Percentage of participants achieving PR or better prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.
Time frame: Up to 5 years
Percentage of Participants with Overall MRD-Negative CR
Percentage of participants who achieve MRD-negative status, as determined by NGS at any time point after randomization and prior to PD or subsequent antimyeloma therapy and who achieve CR or better will be reported.
Time frame: Up to 5 years
Percentage of Participants with 12-Month Sustained MRD-Negative CR
Percentage of participants who achieve MRD-negative CR status, as determined by NGS, for at least 12 months without any examination showing MRD-positive status or PD in between will be reported.
Time frame: Up to 5 years
Progression Free Survival After Subsequent Therapy (PFS2)
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
Time frame: Up to approximately 100 months
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time frame: Up to approximately 100 months
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
Time frame: Baseline up to approximately 100 months
Change from Baseline in HRQoL as Assessed by EORTC-QLQ-C30 Scale Score
The EORTC QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Time frame: Baseline up to approximately 100 months
Change from Baseline in HRQoL as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
The EQ-5D-5L is a self-administered, generic health status measure, consisting of a descriptive system and a visual analog scale (EQ-VAS). The EQ-5D-5L descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), each with 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems) with higher scores indicating worse HRQoL.
Time frame: Baseline up to approximately 100 months
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
The PGI-S is a 2-item questionnaire that assesses severity of the participant's symptoms and impacts of their symptoms, respectively, on a 5-point verbal rating scale, at the time of completing the PRO measure. Score ranges from 1 (None) to 5 (Very Severe). Higher scores indicate greater severity.
Time frame: Baseline up to approximately 100 months
Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46
The EORTC IL46 consists of a single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4 point scale where higher scores indicate more symptoms.
Time frame: Baseline up to approximately 100 months
Percentage of Participants with Tolerability to Ramantamig-D Measured Through Patient Reported Outcomes (PROs)
Percentage of participants with tolerability to ramantamig-D measured through PROs will be reported.
Time frame: Up to approximately 100 months
Showing the first 100 of 103 sites across 14 countries. Choose a country and city above to see the rest.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Israel, South Korea, Turkey (Türkiye), United Kingdom, France, Greece, Netherlands, Poland, Spain, Australia, Czechia, Germany, Italy, Portugal
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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