• Active, not recruiting

NCT03710603: Phase 3 - Daratumumab, VELCADE, Len, Dex VS VELCADE, Len, Dex in NDMM (Perseus) EMN17

Updated: Sep 25

Perseus Study

NDMM

Newly Diagnosed Multiple Myeloma

EMN 17

Perseus study Dara-VRd

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma (Perseus)


Background of the study: The combination of daratumumab with VRd is anticipated to further improve response rates in patients and may lead to improved long-term outcomes in newly diagnosed patients with multiple myeloma. Given this potential, and based upon the initial safety and efficacy observed in the ongoing Phase 2 Study MMY2004, as well as continued positive results with daratumumab in various disease settings and combination regimens, this Phase 3 study is designed to demonstrate improved outcomes for patients treated with daratumumab+VRd.


The Phase 3 study will utilize the subcutaneous (SC) formulation of daratumumab instead of the IV formulation utilized in the Phase 2 study, which may limit additional toxicity to patients treated with the quadruplet regimen.


Sponsor

European Myeloma Network


Collaborator

Janssen Research & Development, LLC

 

ClinicalTrials.gov Identifier: NCT03710603

Official Title: A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Previously Untreated Multiple Myeloma Who Are Eligible for High-dose Therapy

First Posted: October 18, 2018

Click here for details on ClinicalTrials.gov


EMN17 - European Myeloma Network (myeloma-europe.org)

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Daratumumab and Hyaluronidase-fihj Injection: National Cancer Institute

Daratumumab and Hyaluronidase-fihj Injection: MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information


 

Drug: Daratumumab

Drug: velcade

Drug: Lenalidomide

Drug: dexamethasone

 

Locations

Australia

Europe

France

Italy

Netherlands

Spain

Belgium

Czechia

Denmark

Greece

Norway

Poland

Switzerland

Turkey

 

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