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

PLEIADES study

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

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

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ClinicalTrials.gov Identifier: NCT03412565