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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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
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
  • 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

    Recruiting

Other trials in Turkey (Türkiye)

Israel6 sites, 6 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

    Recruiting

Other trials in Israel

South Korea4 sites, 4 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

    Recruiting

Other trials in South Korea

United Kingdom3 sites, 3 recruiting
  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

    Recruiting
  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Recruiting
  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

    Recruiting

Other trials in United Kingdom

France2 sites, 2 recruiting
  • CHU Nantes

    Nantes, 44000

    Recruiting
  • CHU Lyon Sud

    Pierre-Bénite, 69495

    Recruiting

Other trials in France

Greece2 sites, 2 recruiting
  • Evangelismos S A

    Athens, 106 76

    Recruiting
  • Alexandra General Hospital of Athens

    Athens, 11528

    Recruiting

Other trials in Greece

Poland2 sites, 2 recruiting
  • Pratia Onkologia Katowice

    Katowice, 40 519

    Recruiting
  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20 081

    Recruiting

Other trials in Poland

Spain2 sites, 2 recruiting
  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

    Recruiting
  • Hosp. Univ. Dr. Peset

    Valencia, 46017

    Recruiting

Other trials in Spain

Netherlands1 site, 1 recruiting
  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435CM

    Recruiting

Other trials in Netherlands

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.

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 groups in NCT07665450
Study groupRoleWhat they receive
Arm A: Ramantamig plus Daratumumab (Ramantamig-D)ExperimentalParticipants will receive ramantamig D subcutaneous injection.
Receives: Drug: Ramantamig; Drug: Daratumumab
Arm B: Investigator's Choice (DVRd or DRd)Active comparatorParticipants 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted24 Jun 2026
  2. Study start9 Sep 2026
  3. Primary completion4 Sep 2030 (estimated)
  4. Study completion2 Feb 2035 (estimated)

Resources

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)
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.

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