• Active, not recruiting

NCT02195479 : A Phase 3, Study of Bortezomib, Melphalan, Prednisone & Daratumumab ALCYONE trial

Updated: Sep 25

ALCYONE trial


NCT02195479: Phase 3: A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma

ALCYONE trial dara-vmp

The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).


A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma


Sponsor

Janssen Research & Development, LLC

Multiple Locations

International Study

 

ClinicalTrials.gov Identifier: NCT02195479

Official Title: A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy

First Posted: July 21, 2014

Click here for details on ClinicalTrials.gov

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Melphalan: National Cancer Institute

Melphalan: MedlinePlus Drug Information


Prednisone: National Cancer Institute

Prednisone: MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

 

Drug: Velcade

Drug: Melphalan

Drug: Prednisone

Drug: Daratumumab IV

Drug: Dexamethasone

Drug: Daratumumab SC

 

Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma

N Engl J Med; Feb 2018

Click here to see details.

Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial.

Lancet. 2020 Jan 11

Click here to see details.


Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE

Clin Lymphoma Myeloma Leuk; 2021

Click here to see details.


Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA

Blood; 2022

Click here to see details


Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE

Blood: 2022

Click here to see details


Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial

BMC Cancer; 2021

Click here to see details

 

Locations

United States, California

United States, Florida

United States, Illinois

United States, Missouri

United States, Ohio

United States, Virginia

South America

Argentina

Brazil

Australia

Europe

United Kingdom

Belgium

Bulgaria

Croatia

Czechia

Georgia

Germany

Greece

Hungary

Poland

North Macedonia

Portugal

Romania

Serbia

Spain

Turkey

Ukraine

Asia

Japan

Korea, Republic of

Russian Federation

 

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