- Active, not recruiting
NCT02195479 : A Phase 3, Study of Bortezomib, Melphalan, Prednisone & Daratumumab ALCYONE trial
Updated: Sep 25, 2022
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
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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