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
- 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 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.
- Acronym
- TRIlogy-7
- Short 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
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2035-02-02
- First posted
- 2026-06-24
- Registry last updated
- 2026-08-28
- Primary completion date
- 2030-09-04
- Start date
- 2026-09-22
- Participants
- 1,000
- Participant count basis
- Estimated
- Planned participants
- 1,000
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Janssen Research & Development, LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07665450
- ClinicalTrials.gov ID
- NCT07665450
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Progression-Free Survival (PFS)
Timeframe: Up to approximately 62 months
PFS is defined as the time from treatment assignment (that is, randomization in the trial) to confirmed progression of disease (PD) or death, whichever occurs first.
Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response CR
Timeframe: Up to 12 months
12-month MRD-negative CR rate is defined as achieving MRD-negative status at the analysis time window of 12 months (+/-3 months), as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, CR or better must be achieved any time from randomization up to and including 12+3 months, according to international myeloma working group (IMWG) criteria.
Overall Survival (OS)
Timeframe: Up to approximately 100 months
OS is defined as time from treatment assignment (that is, randomization in the trial) to date of death due to any cause.
Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR
Timeframe: Up to 5 years
24-month sustained MRD-negative CR is defined as achieving confirmed CR or better while sustaining MRD-negative status for at least 24 months without any examination showing MRD positive status or PD in between.
Percentage of Participants with Very Good Partial Response (VGPR) or Better
Timeframe: Up to 5 years
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.
Percentage of Participants with CR or Better
Timeframe: Up to 5 years
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.
Percentage of Participants with Overall Response
Timeframe: Up to 5 years
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.
Percentage of Participants with Overall MRD-Negative CR
Timeframe: Up to 5 years
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.
Percentage of Participants with 12-Month Sustained MRD-Negative CR
Timeframe: Up to 5 years
Percentage of participants with confirmed CR or better who sustain MRD-negative status, as determined by NGS, for at least 12 months without any examination showing MRD-positive status or PD in between will be reported.
Progression Free Survival After Subsequent Therapy (PFS2)
Timeframe: Up to approximately 100 months
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.
Number of Participants with Adverse Events (AEs)
Timeframe: Up to approximately 100 months
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.
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Timeframe: Baseline up to approximately 100 months
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.
Change from Baseline in HRQoL as Assessed by EORTC-QLQ-C30 Scale Score
Timeframe: Baseline up to approximately 100 months
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.
Change from Baseline in HRQoL as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
Timeframe: Baseline up to approximately 100 months
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.
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Timeframe: Baseline up to approximately 100 months
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.
Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46
Timeframe: Baseline up to approximately 100 months
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.
Percentage of Participants with Tolerability to Ramantamig-D Measured Through Patient Reported Outcomes (PROs)
Timeframe: Up to approximately 100 months
Percentage of participants with tolerability to ramantamig-D measured through PROs will be reported.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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; or iii. deferral of high-dose chemotherapy with ASCT as initial treatment
- 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
- 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 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
Related records
Drugs (4)
Lead sponsors (1)
Conditions (1)
- Plasma cell myeloma Primary condition