Multiple MyelomaPhase 3TRIlogy-7NCT07665450
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 study testing Ramantamig, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 30 sites in 9 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ramantamig, Daratumumab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 30 sitesin 9 countries
- Study dates
- 9 Sep 2026to 2 Feb 2035
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 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
Trial locations and contacts
30 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 9 countries
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, 06620
- Recruiting
Liv Hospital Ankara
Ankara, 06680
- Recruiting
Memorial Antalya Hastanesi
Antalya, 07025
- Recruiting
Akdeniz Universitesi Tip Fakultesi
Antalya, 07070
- Recruiting
Medipol Mega University Hospital
Istanbul, 34214
- Recruiting
Istanbul Florence Nightingale Hastanesi
Istanbul, 34381
- Recruiting
Izmir Tinaztepe Universitesi Ozel Galen Hastanesi
Izmir, 35001
- Recruiting
Ondokuz Mayis University
Samsun, 55139
Israel6 sites, 6 recruiting
- Recruiting
Rambam Med.Center - Hematology Institute
Haifa, 3109601
- Recruiting
Carmel Medical Center
Haifa, 3436212
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- Recruiting
Rabin Medical Center
Petah Tikva, 4941492
- Recruiting
Sheba Medical Center
Ramat Gan, 5262000
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
South Korea4 sites, 4 recruiting
- Recruiting
The Catholic University of Korea Eunpyeong St Marys Hospital
Seoul, 03312
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
United Kingdom3 sites, 3 recruiting
- Recruiting
Blackpool Victoria Hospital
Blackpool, FY3 8NR
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
- Recruiting
Kent and Canterbury Hospital
Canterbury, CT1 3NG
France2 sites, 2 recruiting
- Recruiting
CHU Nantes
Nantes, 44000
- Recruiting
CHU Lyon Sud
Pierre-Bénite, 69495
Greece2 sites, 2 recruiting
- Recruiting
Evangelismos S A
Athens, 106 76
- Recruiting
Alexandra General Hospital of Athens
Athens, 11528
Poland2 sites, 2 recruiting
- Recruiting
Pratia Onkologia Katowice
Katowice, 40 519
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Lublin, 20 081
Spain2 sites, 2 recruiting
- Recruiting
Hosp. Univ. Infanta Leonor
Madrid, 28031
- Recruiting
Hosp. Univ. Dr. Peset
Valencia, 46017
Netherlands1 site, 1 recruiting
- Recruiting
Sint Antonius Ziekenhuis
Nieuwegein, 3435CM
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Ramantamig, Daratumumab, Lenalidomide, Bortezomib, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamantamigDrug
Ramantamig will be administered subcutaneously.
DaratumumabDrug
Daratumumab will be administered subcutaneously.
LenalidomideDrug
Lenalidomide will be administered orally.
BortezomibDrug
Bortezomib will be administered subcutaneously or intravenously.
DexamethasoneDrug
Dexamethasone will be administered orally or intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ramantamig plus Daratumumab (Ramantamig-D) | Experimental | Participants will receive ramantamig D subcutaneous injection. Receives: Drug: Ramantamig; Drug: Daratumumab |
| Arm B: Investigator's Choice (DVRd or DRd) | Active comparator | Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice. Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the duration from randomization to either confirmed progression of disease (PD) or death, whichever occurs first.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start9 Sep 2026
- Primary completion4 Sep 2030 (estimated)
- Study completion2 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development LLC Clinical trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665450
- Sponsor's protocol ID
- 79635322MMY3004
- Acronym
- TRIlogy-7
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.