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

Official Title: A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

First Posted : January 26, 2018

Click here for details on ClinicalTrials.gov

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Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information

Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

Prednisone : National Cancer Institute

Prednisone : MedlinePlus Drug Information

Melphalan : National Cancer Institute

Melphalan : MedlinePlus Drug Information

Carfilzomib : National Cancer Institute

Carfilzomib : MedlinePlus Drug Information

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

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Drug: Daratumumab

Drug: Bortezomib

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Melphalan

Drug: Prednisone

Drug: Carfilzomib

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Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label Phase II study

Br J Haematol; 2021 March

https://pubmed.ncbi.nlm.nih.gov/33216361/

1380 Subcutaneous Daratumumab (DARA SC) Plus Standard-of-Care (SoC) Regimens in Multiple Myeloma (MM) across Lines of Therapy in the Phase 2 Pleiades Study: Initial Results of the Dara SC Plus Carfilzomib/Dexamethasone (D-Kd) Cohort, and Updated Results for the Dara SC Plus Bortezomib/Melphalan/Prednisone (D-VMP) and Dara SC Plus Lenalidomide/Dexamethasone (D-Rd) Cohorts

62nd ASH Annual Meeting

Saturday, December 5, 2020

https://ash.confex.com/ash/2020/webprogram/Paper134935.html

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- Multiple locations

- Florida: Mayo Clinic Jacksonville Florida

- New York: NYU Langone Medical Center New York

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- North Carolina: Wake Forest Baptist Health Winston-Salem

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Locations

United States, Connecticut

United States, Florida

United States, Idaho

United States, Michigan

United States, Montana

United States, Nebraska

United States, New Mexico

United States, New York

United States, North Carolina

United States, South Carolina

United States, South Dakota

United States, Utah

United States, Virginia

Brazil

Europe

United Kingdom

France

Germany

Spain

Czechia

Asia

Israel

Japan