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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07665450




Registration number
Help: Registration number
NCT07665450
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
18/06/2026
Date registered
Help: Date registered
24/06/2026
Date last updated
Help: Date last updated
3/11/2026

Titles & IDs
Public 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
Scientific 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
Additional trial identifiers [1] 0 0
79635322MMY3004
Universal Trial Number (UTN)
Trial acronym
TRIlogy-7
Related trial records

Health condition
Health condition(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - Ramantamig
Treatment: Drugs - Daratumumab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone

Experimental: Arm A: Ramantamig plus Daratumumab (Ramantamig-D) - Participants will receive ramantamig D subcutaneous injection.

Active comparator: Arm B: Investigator's Choice (DVRd or DRd) - Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.


Treatment: Drugs: Ramantamig
Ramantamig will be administered subcutaneously.

Treatment: Drugs: Daratumumab
Daratumumab will be administered subcutaneously.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered orally.

Treatment: Drugs: Bortezomib
Bortezomib will be administered subcutaneously or intravenously.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered orally or intravenously.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 62 months
Primary outcome [2] 0 0
Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 100 months
Secondary outcome [2] 0 0
Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Percentage of Participants with Very Good Partial Response (VGPR) or Better
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Percentage of Participants with CR or Better
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Percentage of Participants with Overall Response
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Percentage of Participants with Overall MRD-Negative CR
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Percentage of Participants with 12-Month Sustained MRD-Negative CR
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Progression Free Survival After Subsequent Therapy (PFS2)
Timepoint [8] 0 0
Up to approximately 100 months
Secondary outcome [9] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [9] 0 0
Up to approximately 100 months
Secondary outcome [10] 0 0
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Timepoint [10] 0 0
Baseline up to approximately 100 months
Secondary outcome [11] 0 0
Change from Baseline in HRQoL as Assessed by EORTC-QLQ-C30 Scale Score
Timepoint [11] 0 0
Baseline up to approximately 100 months
Secondary outcome [12] 0 0
Change from Baseline in HRQoL as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
Timepoint [12] 0 0
Baseline up to approximately 100 months
Secondary outcome [13] 0 0
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Timepoint [13] 0 0
Baseline up to approximately 100 months
Secondary outcome [14] 0 0
Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46
Timepoint [14] 0 0
Baseline up to approximately 100 months
Secondary outcome [15] 0 0
Percentage of Participants with Tolerability to Ramantamig-D Measured Through Patient Reported Outcomes (PROs)
Timepoint [15] 0 0
Up to approximately 100 months

Eligibility
Key inclusion 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
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/02/2035
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent s Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Brno
Country [2] 0 0
Czechia
State/province [2] 0 0
Hradec Králové
Country [3] 0 0
Czechia
State/province [3] 0 0
Ostrava
Country [4] 0 0
Czechia
State/province [4] 0 0
Pilsen
Country [5] 0 0
Czechia
State/province [5] 0 0
Prague
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Montpellier
Country [8] 0 0
France
State/province [8] 0 0
Nantes
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Pessac
Country [11] 0 0
France
State/province [11] 0 0
Pierre-Bénite
Country [12] 0 0
France
State/province [12] 0 0
Toulouse
Country [13] 0 0
France
State/province [13] 0 0
Tours
Country [14] 0 0
France
State/province [14] 0 0
Vandœuvre-lès-Nancy
Country [15] 0 0
Germany
State/province [15] 0 0
Hamm
Country [16] 0 0
Germany
State/province [16] 0 0
Würzburg
Country [17] 0 0
Greece
State/province [17] 0 0
Alexandroupoli
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Thessaloniki
Country [20] 0 0
Israel
State/province [20] 0 0
Haifa
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Israel
State/province [22] 0 0
Petah Tikva
Country [23] 0 0
Israel
State/province [23] 0 0
Ramat Gan
Country [24] 0 0
Israel
State/province [24] 0 0
Tel Aviv
Country [25] 0 0
Italy
State/province [25] 0 0
Bologna
Country [26] 0 0
Italy
State/province [26] 0 0
Cuneo
Country [27] 0 0
Italy
State/province [27] 0 0
Milan
Country [28] 0 0
Italy
State/province [28] 0 0
Palermo
Country [29] 0 0
Netherlands
State/province [29] 0 0
Eindhoven
Country [30] 0 0
Netherlands
State/province [30] 0 0
Groningen
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nieuwegein
Country [32] 0 0
Netherlands
State/province [32] 0 0
Sittard-Geleen
Country [33] 0 0
Netherlands
State/province [33] 0 0
Utrecht
Country [34] 0 0
Poland
State/province [34] 0 0
Bydgoszcz
Country [35] 0 0
Poland
State/province [35] 0 0
Chorzów
Country [36] 0 0
Poland
State/province [36] 0 0
Gdansk
Country [37] 0 0
Poland
State/province [37] 0 0
Katowice
Country [38] 0 0
Poland
State/province [38] 0 0
Kielce
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Poland
State/province [40] 0 0
Lublin
Country [41] 0 0
Poland
State/province [41] 0 0
Szczecin
Country [42] 0 0
Poland
State/province [42] 0 0
Wroclaw
Country [43] 0 0
Portugal
State/province [43] 0 0
Braga
Country [44] 0 0
Portugal
State/province [44] 0 0
Lisbon
Country [45] 0 0
Portugal
State/province [45] 0 0
Porto
Country [46] 0 0
Portugal
State/province [46] 0 0
Vila Real
Country [47] 0 0
South Korea
State/province [47] 0 0
Gyeonggi-do
Country [48] 0 0
South Korea
State/province [48] 0 0
Jeollanam-do
Country [49] 0 0
South Korea
State/province [49] 0 0
Seoul
Country [50] 0 0
South Korea
State/province [50] 0 0
Ulsan
Country [51] 0 0
Spain
State/province [51] 0 0
Badalona
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Cáceres
Country [54] 0 0
Spain
State/province [54] 0 0
Granada
Country [55] 0 0
Spain
State/province [55] 0 0
Jerez de la Frontera
Country [56] 0 0
Spain
State/province [56] 0 0
León
Country [57] 0 0
Spain
State/province [57] 0 0
Lugo
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Pamplona
Country [60] 0 0
Spain
State/province [60] 0 0
Pozuelo de Alarcón
Country [61] 0 0
Spain
State/province [61] 0 0
Salamanca
Country [62] 0 0
Spain
State/province [62] 0 0
Santander
Country [63] 0 0
Spain
State/province [63] 0 0
Seville
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
Spain
State/province [65] 0 0
Zaragoza
Country [66] 0 0
Turkey (Türkiye)
State/province [66] 0 0
Ankara
Country [67] 0 0
Turkey (Türkiye)
State/province [67] 0 0
Antalya
Country [68] 0 0
Turkey (Türkiye)
State/province [68] 0 0
Istanbul
Country [69] 0 0
Turkey (Türkiye)
State/province [69] 0 0
Izmir
Country [70] 0 0
Turkey (Türkiye)
State/province [70] 0 0
Samsun
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Birmingham
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Blackpool
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Bristol
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Cambridge
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Canterbury
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Colchester
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Edinburgh
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Heath Town
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development LLC Clinical trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07665450