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Clinical Trials in Poland / NCT07665450
Recruiting Phase 3

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

NCT07665450 · tracked via the Priya Life Science Poland tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2026-09-09
Last updated
2026-09-25

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Ramantamig →Daratumumab →Lenalidomide →Bortezomib →Dexamethasone →

Ramantamig: Ramantamig will be administered subcutaneously.

Daratumumab: Daratumumab will be administered subcutaneously.

Lenalidomide: Lenalidomide will be administered orally.

Bortezomib: Bortezomib will be administered subcutaneously or intravenously.

Dexamethasone: Dexamethasone will be administered orally or intravenously.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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; 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 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 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

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — 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 — 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.

Trial sites (19)

FacilityCityRegionStatus
Rambam Med.Center - Hematology Institute Haifa Israel Recruiting
Carmel Medical Center Haifa Israel Recruiting
Shaare Zedek Medical Center Jerusalem Israel Recruiting
Rabin Medical Center Petah Tikva Israel Recruiting
Sheba Medical Center Ramat Gan Israel Recruiting
Tel Aviv Sourasky Medical Center Tel Aviv Israel Recruiting
The Catholic University of Korea Eunpyeong St Marys Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
The Catholic University of Korea Seoul St Mary s Hospital Seoul South Korea Recruiting
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi Ankara Turkey (Türkiye) Recruiting
Liv Hospital Ankara Ankara Turkey (Türkiye) Recruiting
Medipol Mega University Hospital Istanbul Turkey (Türkiye) Recruiting
Istanbul Florence Nightingale Hastanesi Istanbul Turkey (Türkiye) Recruiting
Izmir Tinaztepe Universitesi Ozel Galen Hastanesi Izmir Turkey (Türkiye) Recruiting
Ondokuz Mayis University Samsun Turkey (Türkiye) Recruiting
Blackpool Victoria Hospital Blackpool United Kingdom Recruiting
Addenbrooke's Hospital Cambridge United Kingdom Recruiting
Kent and Canterbury Hospital Canterbury United Kingdom Recruiting

On this site

📄 Darzalex (daratumumab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More Janssen Research & Development, LLC trials in Poland

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide Active, not recruiting
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis Recruiting
A Study of Guselkumab in Participants With Active Psoriatic Arthritis Active, not recruiting
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation Active, not recruiting
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease Active, not recruiting

Other trials for the same condition

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide Active, not recruiting
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting
Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma Active, not recruiting
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy Active, not recruiting
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07665450 on ClinicalTrials.gov ↗ ← All trials in Poland