top of page
  • Active, not recruiting

NCT03412565: Phase 2 - Subcutaneous Daratumumab in Combination With Standard MM Regimens - PLEIADES

Updated: May 24, 2022


PLEIADES study

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimen


PLEIADES

MMY2040 (PLEIADES) Study


NDMM : Newly diagnosed Multiple Myeloma


RRMM : Relapsed & Refractory Multiple Myeloma


PLEIADES is a multicentre, open-label, Phase II study to investigate the safety and efficacy of DARA SC with standard-of-care regimens, including VRd (D-VRd) in patients with NDMM who are eligible for autologous stem cell transplant (ASCT), VMP (D-VMP) in ASCT-ineligible patients with NDMM and Rd (D-Rd) in patients with RRMM who received ≥1 prior line of therapy


Experimental: Daratumumab(D) + Bortezomib + Lenalidomide + Dexamethasone (D-VRd)

Experimental: Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP)

Experimental: Daratumumab + Lenalidomide + Dexamethasone (D-Rd)

Experimental: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)


The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.


Sponsor

Janssen Research & Development, LLC


Multiple Locations

International Study

 

ClinicalTrials.gov Identifier: NCT03412565