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Clinical Trials in the EU / 2026-526654-14-01
Authorised Phase III

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.

2026-526654-14-01 · tracked via the Priya Life Science EU tracker
Sponsor
Janssen Cilag International
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
16/09/2026
Enrollment target
62
Sites
Netherlands, Czechia

Condition studied

Newly Diagnosed Multiple Myeloma

Investigational medicinal product(s)

Lenalidomide Mylan 20 mg hard capsulesDexamethason 8 mg GALEN TablettenLenalidomide Mylan 25 mg hard capsulesFortecortin® 2 mg TablettenJNJ-79635322Lenalidomide Accord 10 mg hard capsulesLenalidomide Accord 20 mg hard capsulesLenalidomide Mylan 10 mg hard capsulesLenalidomide Accord 25 mg hard capsulesLenalidomide Accord 5 mg hard capsulesLenalidomide Accord 15 mg hard capsulesLenalidomide Mylan 15 mg hard capsulesDARZALEX 1800 mg solution for injectionLenalidomide Mylan 5 mg hard capsulesVELCADE 3.5 mg powder for solution for injectionJNJ-79635322Bortezomib injectionpowderlyophilizedfor solutionBortezomib injectionpowderlyophilizedfor solution

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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)

Official registry record

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

View 2026-526654-14-01 on CTIS ↗ ← All trials in the EU