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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-526654-14-01

Enrollment

221

Registered

2026-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Multiple Myeloma

Brief summary

PFS as assessed by a validated computerized algorithm: time from randomization to confirmed progressive disease (per IMWG response criteria) or death, whichever occurs first., 12-month MRD-negative CR rate: complete response or better (per IMWG response criteria) and MRD negative status, at the analysis time window of 12 months, prior to progressive disease or subsequent antimyeloma therapy (including autologous stem cell transplant)

Interventions

DRUGLenalidomide Mylan 20 mg hard capsules

DRUGDexamethason 8 mg GALEN Tabletten

DRUGLenalidomide Mylan 25 mg hard capsules

DRUGFortecortin® 2 mg Tabletten

DRUGJNJ-79635322

DRUGLenalidomide Accord 10 mg hard capsules

DRUGLenalidomide Accord 20 mg hard capsules

DRUGLenalidomide Mylan 10 mg hard capsules

DRUGLenalidomide Accord 25 mg hard capsules

DRUGLenalidomide Accord 5 mg hard capsules

DRUGLenalidomide Accord 15 mg hard capsules

DRUGLenalidomide Mylan 15 mg hard capsules

DRUGDARZALEX 1800 mg solution for injection

DRUGLenalidomide Mylan 5 mg hard capsules

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGBortezomib injection

DRUGpowder

DRUGlyophilized

DRUGfor solution

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS as assessed by a validated computerized algorithm: time from randomization to confirmed progressive disease (per IMWG response criteria) or death, whichever occurs first., 12-month MRD-negative CR rate: complete response or better (per IMWG response criteria) and MRD negative status, at the analysis time window of 12 months, prior to progressive disease or subsequent antimyeloma therapy (including autologous stem cell transplant)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 19, 2026