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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07665450
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ramantamig — DRUG
    Ramantamig will be administered subcutaneously.
  • Daratumumab — DRUG
    Daratumumab will be administered subcutaneously.
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally.
  • Bortezomib — DRUG
    Bortezomib will be administered subcutaneously or intravenously.
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally or intravenously.

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Sep 14, 2026
Status verified
Jul 2026
Primary completion
Sep 4, 2030
Completion
Feb 2, 2035

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 62 months ]

Central Contacts

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